Dynamic Evaluation of Coronary Intervention Renewal: Drug-Eluting Stents
(2012)
Abstract :
DESCRIPTION (provided by applicant): In the practice of percutaneous coronary intervention (PCI), drug-eluting stents (DES) have become the de facto standard of care in the U.S. However, an intense controversy has emerged as it now appears that DES may significantly increase the late risk of stent thrombosis and all-cause mortality. This disturbing, yet unsubstantiated signal of compromised safety represents a potentially huge public health burden. Since initial approval of DES by the Food and Drug Administration (FDA) in 2003, approximately one million patients in the US alone are treated annually with DES. Thus, even a small excess relative risk, if confirmed, could translate to hundreds if not thousands of excess deaths each year. Therefore, to better understand and provide information about the safety and effectiveness of DES, we propose to extend the follow-up (to 5 full years) of 4,290 recent PCI-treated patients (2004- 2006) from the ongoing National Heart, Lung, and Blood Institute (NHLBI) Dynamic PCI Registry. This effort, coupled with existing long-term follow-up data of Dynamic Registry patients treated with bare-metal stents (BMS), will allow for a long-term evaluation of DES versus BMS in 'real-world' clinical practice. Importantly, this evaluation is not possible with extended follow-up of patients enrolled in the randomized clinical trials that led to FDA approval of DES because up to 60% of DES use today occurs in 'off-label' circumstances. Overall, the research aims are to: (1) Compare 5-year mortality and myocardial infarction between patients treated with DES versus BMS overall, within 'high-risk' subgroups, and by 'off-label' stent use; (2) Evaluate cardiac and non-cardiac causes of mortality among patients treated with DES versus BMS; (3) Compare 5-year mortality and repeat revascularization by the sirolimus-eluting versus paclitaxel-eluting stent overall, within 'high-risk' subgroups, and by 'off-label' stent use; and (4) Investigate mechanisms that contribute to stent thrombosis, myocardial infarction, death, and repeat revascularization in patients treated with BMS and DES. In summary, by extending the active NHLBI Dynamic Registry, we propose to analyze long- term outcome data on several thousand PCI patients treated with BMS and DES. This effort will permit an objective and timely real world evaluation of whether the recent signal of a possible mortality hazard associated with use of DES is real, and whether the recent widespread adoption of DES into clinical practice needs to be significantly altered.
| Project Number : | 2U01HL033292-22 |
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| ICD : | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE |
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| IRG : | CASE |
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Dynamic Evaluation of Coronary Intervention Renewal: Drug-Eluting Stents
(2012)
| Project Number : | 5U01HL033292-23 |
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| ICD : | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE |
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| IRG : | CASE |
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Cardiovascular Events in Women's Ischemia Syndrome Evaluation
(2010)
Abstract :
DESCRIPTION (provided by applicant): The Women's Ischemia Syndrome Evaluation (WISE) study has been a successful and productive four-center prospective study of women clinically referred for coronary angiography for evaluation of symptoms suggestive of ischemia. Its major aims were to improve diagnostic testing for ischemic heart disease and to explore female-specific ischemic heart disease pathophysiology. Initiated in September 1996, recruitment of 936 women was completed in a timely manner by March 2000. Support was awarded for an additional five years of follow-up, and our database was closed in March 2006. A rich longitudinal database on these women is available. We are seeking funding to perform a National Death Index (NDI) search to extend mortality follow-up to an average of eight years (maximum 10 years). Patient names reside at the clinical sites, but to maintain confidentiality, are not included in the WISE database at the coordinating center. Experienced site coordinators will prepare materials to submit to the NDI and send results to the coordinating center. Updated mortality data will be added to the WISE database and analyzed. We will evaluate demographic medical history factors, hormonal status, psychosocial results of baseline diagnostic testing and genetic factors as predictors of mortality. Extension of cardiovascular mortality data will more clearly define prognostic factors for long-term mortality in women with ischemia with and without obstructive disease. With an additional targeted analysis, we will develop a simple, reproducible, angiographic technique to identify micro-vascular dysfunction, by correlating TIMI Frame Count with Doppler Wire determined coronary flow reserve measured in response to adenosine in WISE women with suspected ischemia but no significant coronary artery disease. Availability of a simple diagnostic technique allows clinicians to target these women for aggressive medical therapy aimed at early coronary artery disease and improved prognosis. PUBLIC HEALTH RELEVANCE: Much attention has been focused on the differences between men and women presenting with heart attacks and angina pain. The Women's Ischemia Syndrome Evaluation (WISE) study has been a successful and productive prospective study of women clinically referred for coronary angiography for evaluation of symptoms suggestive of ischemia. The goals of WISE were to improve diagnostic testing for ischemic heart disease and to explore female-specific ischemic heart disease pathophysiology. A National Death Index (NDI) search will be used to extend mortality follow-up for WISE women to an average of eight years (maximum 10). Experienced site coordinators will prepare materials to submit to NDI and send results to the coordinating center where updated mortality data will be added to the WISE database and analyzed. Using our existing database, coronary risk factors, hormonal status, psychosocial, genetic factors, and results of diagnostic tests will be evaluated as predictors of long-term mortality. L:\WISE\WISE R03\FINAL\Narrative.doc
| Project Number : | 1R03AG032631-01 |
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| ICD : | NATIONAL INSTITUTE ON AGING |
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| IRG : | CASE |
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BARI II: A TRIAL OF REVASC. & GLYCEMIC CONTROL IN NIDDM
(2010)
Abstract :
The revised Bypass Angioplasty Revascularization Investigation (BARI) II study proposes to evaluate treatments for Type 2 diabetic patients with angiographically proven coronary artery disease and stable angina or ischemia. For this rapidly growing patient population with very poor prognosis and quality of life, revascularization has been less beneficial than in nondiabetics. Using a factorial design, BARI II will compare revascularization combined with aggressive medical anti-ischemia treatment to aggressive medical anti-ischemia treatment alone; simultaneously, BARI II will compare two glycemic control strategies, insulin sensitization versus insulin provision. All patients will have target HbA1c values < 7.5%, and uniform control of hypertension, dyslipidemia and obesity following recommended guidelines. A total of 2,600 patients will be recruited, randomized, treated, and followed at 30 clinical centers. Five-year mortality will be the primary endpoint analyzed by intention-to-treat. The Coordinating Center (CC) will assume responsibility for overall trial operations including clinical site selection, data management using an Internet system, and statistical analysis. Within the CC will be operational units for the management of diabetes control, lipids and hypertension. Detailed data on potential mechanisms of macrovascular events will be collected with centralized evaluations of ECGs, lipids and HbA1c levels. A fibrinolysis core laboratory will explore the effect of glycemic control strategy on the progression and mechanism of vasculopathy, including changes in PAI-1 activity and gene expression. The investigators will evaluate the relative economic costs associated with revascularization approaches and diabetes control (Separate application for the ECG Core, the Fibrinolysis Core and the Economics Core complement this lead application). This 7-year application includes a 6-month protocol finalization phase, 2 years of patient recruitment and an additional 4.5 years of follow-up. BARI II aims to answer critical scientific questions regarding treatment efficacy in Type 2 diabetic patients with stable CAD. The investigators further expect that this collaborative effort will translate into a new practical clinical paradigm that will be used for treatment of Type II diabetic patients.
| Project Number : | 5U01HL061744-09 |
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| ICD : | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE |
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| IRG : | ZHL1 |
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| Project Terms : | blood glucose, coronary bypass, coronary disorder, diabetes mellitus therapy, heart revascularization, human therapy evaluation, insulin, myocardial ischemia /hypoxia, noninsulin dependent diabetes mellitus angina pectoris, cooperative study, fibrinolysis, heart disorder chemotherapy, insulin sensitivity /resistance, longitudinal human study, nonsurgical revascularization clinical research, human subject |
|---|
BARI II: A TRIAL OF REVASC. & GLYCEMIC CONTROL IN NIDDM
(2010)
Abstract :
The revised Bypass Angioplasty Revascularization Investigation (BARI) II study proposes to evaluate treatments for Type 2 diabetic patients with angiographically proven coronary artery disease and stable angina or ischemia. For this rapidly growing patient population with very poor prognosis and quality of life, revascularization has been less beneficial than in nondiabetics. Using a factorial design, BARI II will compare revascularization combined with aggressive medical anti-ischemia treatment to aggressive medical anti-ischemia treatment alone; simultaneously, BARI II will compare two glycemic control strategies, insulin sensitization versus insulin provision. All patients will have target HbA1c values < 7.5%, and uniform control of hypertension, dyslipidemia and obesity following recommended guidelines. A total of 2,600 patients will be recruited, randomized, treated, and followed at 30 clinical centers. Five-year mortality will be the primary endpoint analyzed by intention-to-treat. The Coordinating Center (CC) will assume responsibility for overall trial operations including clinical site selection, data management using an Internet system, and statistical analysis. Within the CC will be operational units for the management of diabetes control, lipids and hypertension. Detailed data on potential mechanisms of macrovascular events will be collected with centralized evaluations of ECGs, lipids and HbA1c levels. A fibrinolysis core laboratory will explore the effect of glycemic control strategy on the progression and mechanism of vasculopathy, including changes in PAI-1 activity and gene expression. The investigators will evaluate the relative economic costs associated with revascularization approaches and diabetes control (Separate application for the ECG Core, the Fibrinolysis Core and the Economics Core complement this lead application). This 7-year application includes a 6-month protocol finalization phase, 2 years of patient recruitment and an additional 4.5 years of follow-up. BARI II aims to answer critical scientific questions regarding treatment efficacy in Type 2 diabetic patients with stable CAD. The investigators further expect that this collaborative effort will translate into a new practical clinical paradigm that will be used for treatment of Type II diabetic patients.
| Project Number : | 5U01HL061744-08 |
|---|
| ICD : | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE |
|---|
| IRG : | ZHL1 |
|---|
| Project Terms : | blood glucose, coronary bypass, coronary disorder, diabetes mellitus therapy, heart revascularization, human therapy evaluation, insulin, myocardial ischemia /hypoxia, noninsulin dependent diabetes mellitus angina pectoris, cooperative study, fibrinolysis, heart disorder chemotherapy, insulin sensitivity /resistance, longitudinal human study, nonsurgical revascularization clinical research, human subject |
|---|
BARI II: A TRIAL OF REVASC. & GLYCEMIC CONTROL IN NIDDM
(2010)
Abstract :
The revised Bypass Angioplasty Revascularization Investigation (BARI) II study proposes to evaluate treatments for Type 2 diabetic patients with angiographically proven coronary artery disease and stable angina or ischemia. For this rapidly growing patient population with very poor prognosis and quality of life, revascularization has been less beneficial than in nondiabetics. Using a factorial design, BARI II will compare revascularization combined with aggressive medical anti-ischemia treatment to aggressive medical anti-ischemia treatment alone; simultaneously, BARI II will compare two glycemic control strategies, insulin sensitization versus insulin provision. All patients will have target HbA1c values < 7.5%, and uniform control of hypertension, dyslipidemia and obesity following recommended guidelines. A total of 2,600 patients will be recruited, randomized, treated, and followed at 30 clinical centers. Five-year mortality will be the primary endpoint analyzed by intention-to-treat. The Coordinating Center (CC) will assume responsibility for overall trial operations including clinical site selection, data management using an Internet system, and statistical analysis. Within the CC will be operational units for the management of diabetes control, lipids and hypertension. Detailed data on potential mechanisms of macrovascular events will be collected with centralized evaluations of ECGs, lipids and HbA1c levels. A fibrinolysis core laboratory will explore the effect of glycemic control strategy on the progression and mechanism of vasculopathy, including changes in PAI-1 activity and gene expression. The investigators will evaluate the relative economic costs associated with revascularization approaches and diabetes control (Separate application for the ECG Core, the Fibrinolysis Core and the Economics Core complement this lead application). This 7-year application includes a 6-month protocol finalization phase, 2 years of patient recruitment and an additional 4.5 years of follow-up. BARI II aims to answer critical scientific questions regarding treatment efficacy in Type 2 diabetic patients with stable CAD. The investigators further expect that this collaborative effort will translate into a new practical clinical paradigm that will be used for treatment of Type II diabetic patients.
| Project Number : | 5U01HL061744-07 |
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| ICD : | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE |
|---|
| IRG : | ZHL1 |
|---|
| Project Terms : | blood glucose, coronary bypass, coronary disorder, diabetes mellitus therapy, heart revascularization, human therapy evaluation, insulin, myocardial ischemia /hypoxia, noninsulin dependent diabetes mellitus angina pectoris, cooperative study, fibrinolysis, heart disorder chemotherapy, insulin sensitivity /resistance, longitudinal human study, nonsurgical revascularization clinical research, human subject |
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Core C--Biostatistics and Data Management
(2009)
Abstract :
The Biostatistics and Data Management Core (Core C) will support all of the pediatric heart transplantation research projects with statistical analysis and data management. The Core investigators, Drs. Sheryl Kelsey and Maria Mori Brooks, have met and will continue to meet with clinical and laboratory investigators and collaborate in the design of projects, including sample size calculation, definition of measurements and quality control. Core C will interact with all 4 projects and the other cores. Statistical Analysis Strategies include: For Project 1 "Thymic tolerance," primary analysis will focus on the accumulation of number of rejection episodes comparing those who did versus those who did not receive thymus inoculation, and counting process methodology will be used. For Project 2 "Transplant EBV disease," laboratory measures and clinical events will be analyzed comparing patients with high and low EBV viral loads, and outcome data from an experimental protocol will be presented. For Project 3, "Genetic contributions to graft and patient outcomes," statistical models will be created to describe the relationship between outcomes of rejection and explanatory factors of pharmacogenetic, inflammatory and HLA matching. Significant independent predictors of acute and chronic rejection will be sought. The effect of race on rejection over and above genetic and other factors will be evaluated. For Project 4 "Leukocyte gene expression," the Core will determine the level of agreement between gene expression algorithms for predicting allograft rejection and response to therapy versus the observed clinical outcomes. The Biostatistics and Data Management Core will manage and process clinical data received from local projects in Pittsburgh and receive SAS files of clinical data collected in Pittsburgh but initially processed at the University of Alabama in Birmingham. Patient records from 6 sites in the Pediatric Heart Transplant Study will also be forwarded in SAS files to Pittsburgh for Project 3. Core C will receive laboratory data in ACCESS files locally. Standard procedures developed at the Epidemiology Data Center will be used for editing, managing and integrating various data sets as well as for data quality control. SAS will be the primary statistical software used. The Core investigators will collaborate with project investigators to prepare reports of study results.
| Project Number : | 5P50HL074732-039002 |
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| ICD : | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE |
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| IRG : | ZHL1 |
|---|
| Project Terms : | biomedical facility, data management, statistics /biometry heart transplantation, medical record, pediatrics clinical research, human data |
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Core--Biostatistics and Data Management
(2009)
Abstract :
The Biostatistics and Data Management Core (Core C) will support all of the pediatric heart transplantation research projects with statistical analysis and data management. The Core investigators, Drs. Sheryl Kelsey and Maria Mori Brooks, have met and will continue to meet with clinical and laboratory investigators and collaborate in the design of projects, including sample size calculation, definition of measurements and quality control. Core C will interact with all 4 projects and the other cores. Statistical Analysis Strategies include: For Project 1 "Thymic tolerance," primary analysis will focus on the accumulation of number of rejection episodes comparing those who did versus those who did not receive thymus inoculation, and counting process methodology will be used. For Project 2 "Transplant EBV disease," laboratory measures and clinical events will be analyzed comparing patients with high and low EBV viral loads, and outcome data from an experimental protocol will be presented. For Project 3, "Genetic contributions to graft and patient outcomes," statistical models will be created to describe the relationship between outcomes of rejection and explanatory factors of pharmacogenetic, inflammatory and HLA matching. Significant independent predictors of acute and chronic rejection will be sought. The effect of race on rejection over and above genetic and other factors will be evaluated. For Project 4 "Leukocyte gene expression," the Core will determine the level of agreement between gene expression algorithms for predicting allograft rejection and response to therapy versus the observed clinical outcomes. The Biostatistics and Data Management Core will manage and process clinical data received from local projects in Pittsburgh and receive SAS files of clinical data collected in Pittsburgh but initially processed at the University of Alabama in Birmingham. Patient records from 6 sites in the Pediatric Heart Transplant Study will also be forwarded in SAS files to Pittsburgh for Project 3. Core C will receive laboratory data in ACCESS files locally. Standard procedures developed at the Epidemiology Data Center will be used for editing, managing and integrating various data sets as well as for data quality control. SAS will be the primary statistical software used. The Core investigators will collaborate with project investigators to prepare reports of study results.
| Project Number : | 5P50HL074732-049002 |
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| ICD : | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE |
|---|
| IRG : | ZHL1 |
|---|
| Project Terms : | biomedical facility, data management, statistics /biometry heart transplantation, medical record, pediatrics clinical research, human data |
|---|
Core C--Biostatistics and Data Management
(2009)
Abstract :
The Biostatistics and Data Management Core (Core C) will support all of the pediatric heart transplantation research projects with statistical analysis and data management. The Core investigators, Drs. Sheryl Kelsey and Maria Mori Brooks, have met and will continue to meet with clinical and laboratory investigators and collaborate in the design of projects, including sample size calculation, definition of measurements and quality control. Core C will interact with all 4 projects and the other cores. Statistical Analysis Strategies include: For Project 1 "Thymic tolerance," primary analysis will focus on the accumulation of number of rejection episodes comparing those who did versus those who did not receive thymus inoculation, and counting process methodology will be used. For Project 2 "Transplant EBV disease," laboratory measures and clinical events will be analyzed comparing patients with high and low EBV viral loads, and outcome data from an experimental protocol will be presented. For Project 3, "Genetic contributions to graft and patient outcomes," statistical models will be created to describe the relationship between outcomes of rejection and explanatory factors of pharmacogenetic, inflammatory and HLA matching. Significant independent predictors of acute and chronic rejection will be sought. The effect of race on rejection over and above genetic and other factors will be evaluated. For Project 4 "Leukocyte gene expression," the Core will determine the level of agreement between gene expression algorithms for predicting allograft rejection and response to therapy versus the observed clinical outcomes. The Biostatistics and Data Management Core will manage and process clinical data received from local projects in Pittsburgh and receive SAS files of clinical data collected in Pittsburgh but initially processed at the University of Alabama in Birmingham. Patient records from 6 sites in the Pediatric Heart Transplant Study will also be forwarded in SAS files to Pittsburgh for Project 3. Core C will receive laboratory data in ACCESS files locally. Standard procedures developed at the Epidemiology Data Center will be used for editing, managing and integrating various data sets as well as for data quality control. SAS will be the primary statistical software used. The Core investigators will collaborate with project investigators to prepare reports of study results.
| Project Number : | 5P50HL074732-029002 |
|---|
| ICD : | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE |
|---|
| IRG : | ZHL1 |
|---|
| Project Terms : | biomedical facility, data management, statistics /biometry heart transplantation, medical record, pediatrics clinical research, human data |
|---|
Core C--Biostatistics and Data Management
(2008)
Abstract :
The Biostatistics and Data Management Core (Core C) will support all of the pediatric heart transplantation research projects with statistical analysis and data management. The Core investigators, Drs. Sheryl Kelsey and Maria Mori Brooks, have met and will continue to meet with clinical and laboratory investigators and collaborate in the design of projects, including sample size calculation, definition of measurements and quality control. Core C will interact with all 4 projects and the other cores. Statistical Analysis Strategies include: For Project 1 "Thymic tolerance," primary analysis will focus on the accumulation of number of rejection episodes comparing those who did versus those who did not receive thymus inoculation, and counting process methodology will be used. For Project 2 "Transplant EBV disease," laboratory measures and clinical events will be analyzed comparing patients with high and low EBV viral loads, and outcome data from an experimental protocol will be presented. For Project 3, "Genetic contributions to graft and patient outcomes," statistical models will be created to describe the relationship between outcomes of rejection and explanatory factors of pharmacogenetic, inflammatory and HLA matching. Significant independent predictors of acute and chronic rejection will be sought. The effect of race on rejection over and above genetic and other factors will be evaluated. For Project 4 "Leukocyte gene expression," the Core will determine the level of agreement between gene expression algorithms for predicting allograft rejection and response to therapy versus the observed clinical outcomes. The Biostatistics and Data Management Core will manage and process clinical data received from local projects in Pittsburgh and receive SAS files of clinical data collected in Pittsburgh but initially processed at the University of Alabama in Birmingham. Patient records from 6 sites in the Pediatric Heart Transplant Study will also be forwarded in SAS files to Pittsburgh for Project 3. Core C will receive laboratory data in ACCESS files locally. Standard procedures developed at the Epidemiology Data Center will be used for editing, managing and integrating various data sets as well as for data quality control. SAS will be the primary statistical software used. The Core investigators will collaborate with project investigators to prepare reports of study results.
| Project Number : | 1P50HL074732-019002 |
|---|
| ICD : | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE |
|---|
| IRG : | ZHL1 |
|---|
| Project Terms : | biomedical facility, data management, statistics /biometry heart transplantation, medical record, pediatrics clinical research, human data |
|---|
Core--Biostatistics and Data Management
(2008)
Abstract :
The Biostatistics and Data Management Core (Core C) will support all of the pediatric heart transplantation research projects with statistical analysis and data management. The Core investigators, Drs. Sheryl Kelsey and Maria Mori Brooks, have met and will continue to meet with clinical and laboratory investigators and collaborate in the design of projects, including sample size calculation, definition of measurements and quality control. Core C will interact with all 4 projects and the other cores. Statistical Analysis Strategies include: For Project 1 "Thymic tolerance," primary analysis will focus on the accumulation of number of rejection episodes comparing those who did versus those who did not receive thymus inoculation, and counting process methodology will be used. For Project 2 "Transplant EBV disease," laboratory measures and clinical events will be analyzed comparing patients with high and low EBV viral loads, and outcome data from an experimental protocol will be presented. For Project 3, "Genetic contributions to graft and patient outcomes," statistical models will be created to describe the relationship between outcomes of rejection and explanatory factors of pharmacogenetic, inflammatory and HLA matching. Significant independent predictors of acute and chronic rejection will be sought. The effect of race on rejection over and above genetic and other factors will be evaluated. For Project 4 "Leukocyte gene expression," the Core will determine the level of agreement between gene expression algorithms for predicting allograft rejection and response to therapy versus the observed clinical outcomes. The Biostatistics and Data Management Core will manage and process clinical data received from local projects in Pittsburgh and receive SAS files of clinical data collected in Pittsburgh but initially processed at the University of Alabama in Birmingham. Patient records from 6 sites in the Pediatric Heart Transplant Study will also be forwarded in SAS files to Pittsburgh for Project 3. Core C will receive laboratory data in ACCESS files locally. Standard procedures developed at the Epidemiology Data Center will be used for editing, managing and integrating various data sets as well as for data quality control. SAS will be the primary statistical software used. The Core investigators will collaborate with project investigators to prepare reports of study results.
| Project Number : | 5P50HL074732-059002 |
|---|
| ICD : | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE |
|---|
| IRG : | ZHL1 |
|---|
| Project Terms : | biomedical facility, data management, statistics /biometry heart transplantation, medical record, pediatrics clinical research, human data |
|---|
BARI II: A TRIAL OF REVASC. & GLYCEMIC CONTROL IN NIDDM
(2007)
Abstract :
The revised Bypass Angioplasty Revascularization Investigation (BARI) II study proposes to evaluate treatments for Type 2 diabetic patients with angiographically proven coronary artery disease and stable angina or ischemia. For this rapidly growing patient population with very poor prognosis and quality of life, revascularization has been less beneficial than in nondiabetics. Using a factorial design, BARI II will compare revascularization combined with aggressive medical anti-ischemia treatment to aggressive medical anti-ischemia treatment alone; simultaneously, BARI II will compare two glycemic control strategies, insulin sensitization versus insulin provision. All patients will have target HbA1c values < 7.5%, and uniform control of hypertension, dyslipidemia and obesity following recommended guidelines. A total of 2,600 patients will be recruited, randomized, treated, and followed at 30 clinical centers. Five-year mortality will be the primary endpoint analyzed by intention-to-treat. The Coordinating Center (CC) will assume responsibility for overall trial operations including clinical site selection, data management using an Internet system, and statistical analysis. Within the CC will be operational units for the management of diabetes control, lipids and hypertension. Detailed data on potential mechanisms of macrovascular events will be collected with centralized evaluations of ECGs, lipids and HbA1c levels. A fibrinolysis core laboratory will explore the effect of glycemic control strategy on the progression and mechanism of vasculopathy, including changes in PAI-1 activity and gene expression. The investigators will evaluate the relative economic costs associated with revascularization approaches and diabetes control (Separate application for the ECG Core, the Fibrinolysis Core and the Economics Core complement this lead application). This 7-year application includes a 6-month protocol finalization phase, 2 years of patient recruitment and an additional 4.5 years of follow-up. BARI II aims to answer critical scientific questions regarding treatment efficacy in Type 2 diabetic patients with stable CAD. The investigators further expect that this collaborative effort will translate into a new practical clinical paradigm that will be used for treatment of Type II diabetic patients.
| Project Number : | 5U01HL061744-06 |
|---|
| ICD : | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE |
|---|
| IRG : | ZHL1 |
|---|
| Project Terms : | blood glucose, coronary bypass, coronary disorder, diabetes mellitus therapy, heart revascularization, human therapy evaluation, insulin, myocardial ischemia /hypoxia, noninsulin dependent diabetes mellitus angina pectoris, cooperative study, fibrinolysis, heart disorder chemotherapy, insulin sensitivity /resistance, longitudinal human study, nonsurgical revascularization clinical research, human subject |
|---|
Women's Ischemia Syndrome Evaluation
(2007)
Abstract :
This reapplication proposes to extend the follow-up of the Women's Ischemia Syndrome Evaluation (WISE) patients for a minimum of 5 years and is being submitted jointly with the applications "Altered Renin Angiotensin System as a Mechanism for Coronary Microvascular Dysfunction in Women" (C. Pepine PI) and "Immunologic Basis For Coronary Disease in Women" (S.Reis PI). The WISE contract began in September 1996 as a 4-center study to 1) optimize symptom evaluation and diagnostic testing for ischemic heart disease in women; 2) explore mechanisms for symptoms and myocardial ischemia in the absence of epicardial coronary artery stenoses; and 3) evaluate the influence of reproductive hormones on symptoms and diagnostic test response. An extensive contemporary database has been assembled on 936 women referred for coronary angiography because of suspected ischemia. Data include demographic, clinical, sympotmatic, functional, and psychosocial variables. Coronary angiography and ventriculography data, brachial artery reactivity testing, ECG monitoring, and blood determinations are all assessed by core laboratories. Site-specific innovative technologies have been used to develop potential markers of myocardial ischemia. We seek to 1) Determine the incremental long-term prognostic value of novel testing developed in WISE; 2) Develop sex-specific incremental outcome models to evaluate the prognostic value of female reproductive variables; 3) Assess the incremental cost effectiveness and resources efficiency of the WISE innovative testing techniques as compared with traditional tests; 4) Continue ongoing analyses and ancillary projects, collaborate with other WISE investigators Ro1's submitted in this cluster, and maintain a WISE database and infrastructure to facilitate further investigations into the mechanisms underlying ischemia syndromes in women. To address these aims, a longer follow-up is necessary. Follow-up will consist of annual telephone contacts by experienced site coordinators. WISE will continue to use the well-established methods to implement study coordination, data management, quality control, statistical analyses, and manuscript preparation. Cox regression models will be used as explanatory variables. A hybrid decision model will be used that compares resource use patterns and sums cost estimates. The results of these studies will enhance our understanding of both the significance and pathophysiology of ischemic heart disease in women and serve as a foundation for diagnostic and therapeutic clinical trials aimed at reducing disease-related morbidity and mortality.
| Project Number : | 5U01HL064829-05 |
|---|
| ICD : | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE |
|---|
| IRG : | ZHL1 |
|---|
| Project Terms : | cardiovascular disorder diagnosis, cardiovascular disorder epidemiology, diagnosis design /evaluation, myocardial ischemia /hypoxia, women's health cooperative study, cost effectiveness, gender difference, hormone regulation /control mechanism, longitudinal human study, outcomes research, pathologic process, prognosis angiography, electrocardiography, human data, human subject, interview, patient oriented research |
|---|
Women's Ischemia Syndrome Evaluation
(2006)
Abstract :
This reapplication proposes to extend the follow-up of the Women's Ischemia Syndrome Evaluation (WISE) patients for a minimum of 5 years and is being submitted jointly with the applications "Altered Renin Angiotensin System as a Mechanism for Coronary Microvascular Dysfunction in Women" (C. Pepine PI) and "Immunologic Basis For Coronary Disease in Women" (S.Reis PI). The WISE contract began in September 1996 as a 4-center study to 1) optimize symptom evaluation and diagnostic testing for ischemic heart disease in women; 2) explore mechanisms for symptoms and myocardial ischemia in the absence of epicardial coronary artery stenoses; and 3) evaluate the influence of reproductive hormones on symptoms and diagnostic test response. An extensive contemporary database has been assembled on 936 women referred for coronary angiography because of suspected ischemia. Data include demographic, clinical, sympotmatic, functional, and psychosocial variables. Coronary angiography and ventriculography data, brachial artery reactivity testing, ECG monitoring, and blood determinations are all assessed by core laboratories. Site-specific innovative technologies have been used to develop potential markers of myocardial ischemia. We seek to 1) Determine the incremental long-term prognostic value of novel testing developed in WISE; 2) Develop sex-specific incremental outcome models to evaluate the prognostic value of female reproductive variables; 3) Assess the incremental cost effectiveness and resources efficiency of the WISE innovative testing techniques as compared with traditional tests; 4) Continue ongoing analyses and ancillary projects, collaborate with other WISE investigators Ro1's submitted in this cluster, and maintain a WISE database and infrastructure to facilitate further investigations into the mechanisms underlying ischemia syndromes in women. To address these aims, a longer follow-up is necessary. Follow-up will consist of annual telephone contacts by experienced site coordinators. WISE will continue to use the well-established methods to implement study coordination, data management, quality control, statistical analyses, and manuscript preparation. Cox regression models will be used as explanatory variables. A hybrid decision model will be used that compares resource use patterns and sums cost estimates. The results of these studies will enhance our understanding of both the significance and pathophysiology of ischemic heart disease in women and serve as a foundation for diagnostic and therapeutic clinical trials aimed at reducing disease-related morbidity and mortality.
| Project Number : | 1U01HL064829-01A1 |
|---|
| ICD : | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE |
|---|
| IRG : | ZHL1 |
|---|
| Project Terms : | cardiovascular disorder diagnosis, cardiovascular disorder epidemiology, diagnosis design /evaluation, myocardial ischemia /hypoxia, women's health cooperative study, cost effectiveness, gender difference, hormone regulation /control mechanism, longitudinal human study, outcomes research, pathologic process, prognosis angiography, electrocardiography, human data, human subject, interview, patient oriented research |
|---|
Women's Ischemia Syndrome Evaluation
(2006)
Abstract :
This reapplication proposes to extend the follow-up of the Women's Ischemia Syndrome Evaluation (WISE) patients for a minimum of 5 years and is being submitted jointly with the applications "Altered Renin Angiotensin System as a Mechanism for Coronary Microvascular Dysfunction in Women" (C. Pepine PI) and "Immunologic Basis For Coronary Disease in Women" (S.Reis PI). The WISE contract began in September 1996 as a 4-center study to 1) optimize symptom evaluation and diagnostic testing for ischemic heart disease in women; 2) explore mechanisms for symptoms and myocardial ischemia in the absence of epicardial coronary artery stenoses; and 3) evaluate the influence of reproductive hormones on symptoms and diagnostic test response. An extensive contemporary database has been assembled on 936 women referred for coronary angiography because of suspected ischemia. Data include demographic, clinical, sympotmatic, functional, and psychosocial variables. Coronary angiography and ventriculography data, brachial artery reactivity testing, ECG monitoring, and blood determinations are all assessed by core laboratories. Site-specific innovative technologies have been used to develop potential markers of myocardial ischemia. We seek to 1) Determine the incremental long-term prognostic value of novel testing developed in WISE; 2) Develop sex-specific incremental outcome models to evaluate the prognostic value of female reproductive variables; 3) Assess the incremental cost effectiveness and resources efficiency of the WISE innovative testing techniques as compared with traditional tests; 4) Continue ongoing analyses and ancillary projects, collaborate with other WISE investigators Ro1's submitted in this cluster, and maintain a WISE database and infrastructure to facilitate further investigations into the mechanisms underlying ischemia syndromes in women. To address these aims, a longer follow-up is necessary. Follow-up will consist of annual telephone contacts by experienced site coordinators. WISE will continue to use the well-established methods to implement study coordination, data management, quality control, statistical analyses, and manuscript preparation. Cox regression models will be used as explanatory variables. A hybrid decision model will be used that compares resource use patterns and sums cost estimates. The results of these studies will enhance our understanding of both the significance and pathophysiology of ischemic heart disease in women and serve as a foundation for diagnostic and therapeutic clinical trials aimed at reducing disease-related morbidity and mortality.
| Project Number : | 5U01HL064829-02 |
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| ICD : | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE |
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| IRG : | ZHL1 |
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| Project Terms : | cardiovascular disorder diagnosis, cardiovascular disorder epidemiology, diagnosis design /evaluation, myocardial ischemia /hypoxia, women's health cooperative study, cost effectiveness, gender difference, hormone regulation /control mechanism, longitudinal human study, outcomes research, pathologic process, prognosis angiography, electrocardiography, human data, human subject, interview, patient oriented research |
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Women's Ischemia Syndrome Evaluation
(2006)
Abstract :
This reapplication proposes to extend the follow-up of the Women's Ischemia Syndrome Evaluation (WISE) patients for a minimum of 5 years and is being submitted jointly with the applications "Altered Renin Angiotensin System as a Mechanism for Coronary Microvascular Dysfunction in Women" (C. Pepine PI) and "Immunologic Basis For Coronary Disease in Women" (S.Reis PI). The WISE contract began in September 1996 as a 4-center study to 1) optimize symptom evaluation and diagnostic testing for ischemic heart disease in women; 2) explore mechanisms for symptoms and myocardial ischemia in the absence of epicardial coronary artery stenoses; and 3) evaluate the influence of reproductive hormones on symptoms and diagnostic test response. An extensive contemporary database has been assembled on 936 women referred for coronary angiography because of suspected ischemia. Data include demographic, clinical, sympotmatic, functional, and psychosocial variables. Coronary angiography and ventriculography data, brachial artery reactivity testing, ECG monitoring, and blood determinations are all assessed by core laboratories. Site-specific innovative technologies have been used to develop potential markers of myocardial ischemia. We seek to 1) Determine the incremental long-term prognostic value of novel testing developed in WISE; 2) Develop sex-specific incremental outcome models to evaluate the prognostic value of female reproductive variables; 3) Assess the incremental cost effectiveness and resources efficiency of the WISE innovative testing techniques as compared with traditional tests; 4) Continue ongoing analyses and ancillary projects, collaborate with other WISE investigators Ro1's submitted in this cluster, and maintain a WISE database and infrastructure to facilitate further investigations into the mechanisms underlying ischemia syndromes in women. To address these aims, a longer follow-up is necessary. Follow-up will consist of annual telephone contacts by experienced site coordinators. WISE will continue to use the well-established methods to implement study coordination, data management, quality control, statistical analyses, and manuscript preparation. Cox regression models will be used as explanatory variables. A hybrid decision model will be used that compares resource use patterns and sums cost estimates. The results of these studies will enhance our understanding of both the significance and pathophysiology of ischemic heart disease in women and serve as a foundation for diagnostic and therapeutic clinical trials aimed at reducing disease-related morbidity and mortality.
| Project Number : | 5U01HL064829-03 |
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| ICD : | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE |
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| IRG : | ZHL1 |
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| Project Terms : | cardiovascular disorder diagnosis, cardiovascular disorder epidemiology, diagnosis design /evaluation, myocardial ischemia /hypoxia, women's health cooperative study, cost effectiveness, gender difference, hormone regulation /control mechanism, longitudinal human study, outcomes research, pathologic process, prognosis angiography, electrocardiography, human data, human subject, interview, patient oriented research |
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Women's Ischemia Syndrome Evaluation
(2006)
Abstract :
This reapplication proposes to extend the follow-up of the Women's Ischemia Syndrome Evaluation (WISE) patients for a minimum of 5 years and is being submitted jointly with the applications "Altered Renin Angiotensin System as a Mechanism for Coronary Microvascular Dysfunction in Women" (C. Pepine PI) and "Immunologic Basis For Coronary Disease in Women" (S.Reis PI). The WISE contract began in September 1996 as a 4-center study to 1) optimize symptom evaluation and diagnostic testing for ischemic heart disease in women; 2) explore mechanisms for symptoms and myocardial ischemia in the absence of epicardial coronary artery stenoses; and 3) evaluate the influence of reproductive hormones on symptoms and diagnostic test response. An extensive contemporary database has been assembled on 936 women referred for coronary angiography because of suspected ischemia. Data include demographic, clinical, sympotmatic, functional, and psychosocial variables. Coronary angiography and ventriculography data, brachial artery reactivity testing, ECG monitoring, and blood determinations are all assessed by core laboratories. Site-specific innovative technologies have been used to develop potential markers of myocardial ischemia. We seek to 1) Determine the incremental long-term prognostic value of novel testing developed in WISE; 2) Develop sex-specific incremental outcome models to evaluate the prognostic value of female reproductive variables; 3) Assess the incremental cost effectiveness and resources efficiency of the WISE innovative testing techniques as compared with traditional tests; 4) Continue ongoing analyses and ancillary projects, collaborate with other WISE investigators Ro1's submitted in this cluster, and maintain a WISE database and infrastructure to facilitate further investigations into the mechanisms underlying ischemia syndromes in women. To address these aims, a longer follow-up is necessary. Follow-up will consist of annual telephone contacts by experienced site coordinators. WISE will continue to use the well-established methods to implement study coordination, data management, quality control, statistical analyses, and manuscript preparation. Cox regression models will be used as explanatory variables. A hybrid decision model will be used that compares resource use patterns and sums cost estimates. The results of these studies will enhance our understanding of both the significance and pathophysiology of ischemic heart disease in women and serve as a foundation for diagnostic and therapeutic clinical trials aimed at reducing disease-related morbidity and mortality.
| Project Number : | 5U01HL064829-04 |
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| ICD : | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE |
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| IRG : | ZHL1 |
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| Project Terms : | cardiovascular disorder diagnosis, cardiovascular disorder epidemiology, diagnosis design /evaluation, myocardial ischemia /hypoxia, women's health cooperative study, cost effectiveness, gender difference, hormone regulation /control mechanism, longitudinal human study, outcomes research, pathologic process, prognosis angiography, electrocardiography, human data, human subject, interview, patient oriented research |
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CORE--DATA MANAGEMENT, BIOSTATISTICS AND EPIDEMIOLOGY
(1999)
Abstract :
The Data Management, Biostatistics and Epidemiology Core will support all of the brain trauma research center projects with statistical analysis and data management. The Core has and will continue to collaborate in the design of the projects, including sample size calculation, definition of measurements and quality control. For clinical projects the Core will manage the data and perform statistical analysis. For laboratory projects the Core investigators will advise on data management and analysis and, if necessary, assist in carrying out analysis. The Core will collaborate with project investigators to prepare reports of study results. An additional responsibility will be to collaborate with other NINDS head injury centers and contribute data to a common patient database.
| Project Number : | 5P50NS030318-089001 |
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| ICD : | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE |
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| Project Terms : | biomedical facility, brain injury, epidemiology, statistical service /center computer processing of clinical data, data collection methodology /evaluation, information system human data |
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CORE--DATA MANAGEMENT, BIOSTATISTICS AND EPIDEMIOLOGY
(1998)
Abstract :
The Data Management, Biostatistics and Epidemiology Core will support all of the brain trauma research center projects with statistical analysis and data management. The Core has and will continue to collaborate in the design of the projects, including sample size calculation, definition of measurements and quality control. For clinical projects the Core will manage the data and perform statistical analysis. For laboratory projects the Core investigators will advise on data management and analysis and, if necessary, assist in carrying out analysis. The Core will collaborate with project investigators to prepare reports of study results. An additional responsibility will be to collaborate with other NINDS head injury centers and contribute data to a common patient database.
| Project Number : | 2P50NS030318-079001 |
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| ICD : | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE |
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| Project Terms : | biomedical facility, brain injury, epidemiology, statistical service /center computer processing of clinical data, data collection methodology /evaluation, information system human data |
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CORE--DATA MANAGEMENT, BIOSTATISTICS AND EPIDEMIOLOGY
(1997)
Abstract :
The Data Management, Biostatistics and Epidemiology Core will support all of the brain trauma research center projects with statistical analysis and data management. The Core has and will continue to collaborate in the design of the projects, including sample size calculation, definition of measurements and quality control. For clinical projects the Core will manage the data and perform statistical analysis. For laboratory projects the Core investigators will advise on data management and analysis and, if necessary, assist in carrying out analysis. The Core will collaborate with project investigators to prepare reports of study results. An additional responsibility will be to collaborate with other NINDS head injury centers and contribute data to a common patient database.
| Project Number : | 2P50NS030318-069001 |
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| ICD : | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE |
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| Project Terms : | biomedical facility, brain injury, epidemiology, statistical service /center computer processing of clinical data, data collection methodology /evaluation, information system human data |
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ENDOPHTHALMITIS VITRECTOMY STUDY COORDINATING CENTER
(1996)
Abstract :
The Endophthalmitis Vitrectomy Study (EVS) is a prospective, randomized, multicenter clinical trial designed to determine the role of pars plana vitrectomy in the initial management of patients with bacterial endophthalmitis. This is an application to serve as Coordinating Center for this study, with primary responsibility for study organization, data management and statistical analysis. The accompanying Study chair application presents the study protocol and includes as appendices the manual operation and data collection forms. Investigators from the Epidemiology Data Center at the University of Pittsburgh propose to continue to work with the Study Chair and other clinical investigators to make final revisions to study protocol, manual of operations and data collection forms. The Coordinating Center will be responsible for preparing the randomized scheme, interim monitoring and reporting to the Safety and Data Monitoring Committee. Data will be received, processed and managed on the Data Center system of IBM microcomputers and mainframe VAX. The trial will compare treatment strategies for endophthalmitis and as such "intention to treat" will be primary method of analysis. Analysis methods will be developed and tested during data acquisition phases and final analysis and reports will be generated during the last phase.
| Project Number : | 5U10EY008151-05 |
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| ICD : | NATIONAL EYE INSTITUTE |
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| IRG : | VSN |
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ENDOPHTHALMITIS VITRECTOMY STUDY COORDINATING CENTER
(1996)
Abstract :
The Endophthalmitis Vitrectomy Study (EVS) is a prospective, randomized, multicenter clinical trial designed to determine the role of pars plana vitrectomy in the initial management of patients with bacterial endophthalmitis. This is an application to serve as Coordinating Center for this study, with primary responsibility for study organization, data management and statistical analysis. The accompanying Study chair application presents the study protocol and includes as appendices the manual operation and data collection forms. Investigators from the Epidemiology Data Center at the University of Pittsburgh propose to continue to work with the Study Chair and other clinical investigators to make final revisions to study protocol, manual of operations and data collection forms. The Coordinating Center will be responsible for preparing the randomized scheme, interim monitoring and reporting to the Safety and Data Monitoring Committee. Data will be received, processed and managed on the Data Center system of IBM microcomputers and mainframe VAX. The trial will compare treatment strategies for endophthalmitis and as such "intention to treat" will be primary method of analysis. Analysis methods will be developed and tested during data acquisition phases and final analysis and reports will be generated during the last phase.
| Project Number : | 3U10EY008151-05S1 |
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| ICD : | NATIONAL EYE INSTITUTE |
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| IRG : | VSN |
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ENDOPHTHALMITIS VITRECTOMY STUDY COORDINATING CENTER
(1996)
| Project Number : | 3U10EY008151-05S2 |
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| ICD : | NATIONAL EYE INSTITUTE |
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| IRG : | VSN |
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ENDOPHTHALMITIS VITRECTOMY STUDY COORDINATING CENTER
(1994)
Abstract :
The Endophthalmitis Vitrectomy Study (EVS) is a prospective, randomized, multicenter clinical trial designed to determine the role of pars plana vitrectomy in the initial management of patients with bacterial endophthalmitis. This is an application to serve as Coordinating Center for this study, with primary responsibility for study organization, data management and statistical analysis. The accompanying Study chair application presents the study protocol and includes as appendices the manual operation and data collection forms. Investigators from the Epidemiology Data Center at the University of Pittsburgh propose to continue to work with the Study Chair and other clinical investigators to make final revisions to study protocol, manual of operations and data collection forms. The Coordinating Center will be responsible for preparing the randomized scheme, interim monitoring and reporting to the Safety and Data Monitoring Committee. Data will be received, processed and managed on the Data Center system of IBM microcomputers and mainframe VAX. The trial will compare treatment strategies for endophthalmitis and as such "intention to treat" will be primary method of analysis. Analysis methods will be developed and tested during data acquisition phases and final analysis and reports will be generated during the last phase.
| Project Number : | 1U01EY008151-01 |
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| ICD : | NATIONAL EYE INSTITUTE |
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| IRG : | VSN |
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| Project Terms : | ANTIBIOTICS, EYE DISORDERS, UVEA DISORDERS, UVEITIS, EYE SURGERY, KERATOPLASTY, REFRACTIVE KERATOPLASTY DISEASES, COMPLICATIONS, POSTOPERATIVE, DOSAGE AND ROUTE, INJECTIONS, DOSAGE AND ROUTE, ROUTE OF ADMINISTRATION, EYE SURGERY, CATARACT SURGERY, EYE, ANTERIOR CHAMBER, POPULATION STUDIES HUMAN, LONGITUDINAL STUDY, cooperative study, eye pharmacology HUMAN, CLINICAL |
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ENDOPHTHALMITIS VITRECTOMY STUDY COORDINATING CENTER
(1994)
| Project Number : | 3U10EY008151-01S1 |
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| ICD : | NATIONAL EYE INSTITUTE |
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| IRG : | VSN |
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ENDOPHTHALMITIS VITRECTOMY STUDY COORDINATING CENTER
(1994)
Abstract :
The Endophthalmitis Vitrectomy Study (EVS) is a prospective, randomized, multicenter clinical trial designed to determine the role of pars plana vitrectomy in the initial management of patients with bacterial endophthalmitis. This is an application to serve as Coordinating Center for this study, with primary responsibility for study organization, data management and statistical analysis. The accompanying Study chair application presents the study protocol and includes as appendices the manual operation and data collection forms. Investigators from the Epidemiology Data Center at the University of Pittsburgh propose to continue to work with the Study Chair and other clinical investigators to make final revisions to study protocol, manual of operations and data collection forms. The Coordinating Center will be responsible for preparing the randomized scheme, interim monitoring and reporting to the Safety and Data Monitoring Committee. Data will be received, processed and managed on the Data Center system of IBM microcomputers and mainframe VAX. The trial will compare treatment strategies for endophthalmitis and as such "intention to treat" will be primary method of analysis. Analysis methods will be developed and tested during data acquisition phases and final analysis and reports will be generated during the last phase.
| Project Number : | 5U10EY008151-02 |
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| ICD : | NATIONAL EYE INSTITUTE |
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| IRG : | VSN |
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| Project Terms : | ANTIBIOTICS, EYE DISORDERS, UVEA DISORDERS, UVEITIS, EYE SURGERY, KERATOPLASTY, REFRACTIVE KERATOPLASTY DISEASES, COMPLICATIONS, POSTOPERATIVE, DOSAGE AND ROUTE, INJECTIONS, DOSAGE AND ROUTE, ROUTE OF ADMINISTRATION, EYE SURGERY, CATARACT SURGERY, EYE, ANTERIOR CHAMBER, POPULATION STUDIES HUMAN, LONGITUDINAL STUDY, cooperative study, eye pharmacology HUMAN, CLINICAL |
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ENDOPHTHALMITIS VITRECTOMY STUDY COORDINATING CENTER
(1994)
Abstract :
The Endophthalmitis Vitrectomy Study (EVS) is a prospective, randomized, multicenter clinical trial designed to determine the role of pars plana vitrectomy in the initial management of patients with bacterial endophthalmitis. This is an application to serve as Coordinating Center for this study, with primary responsibility for study organization, data management and statistical analysis. The accompanying Study chair application presents the study protocol and includes as appendices the manual operation and data collection forms. Investigators from the Epidemiology Data Center at the University of Pittsburgh propose to continue to work with the Study Chair and other clinical investigators to make final revisions to study protocol, manual of operations and data collection forms. The Coordinating Center will be responsible for preparing the randomized scheme, interim monitoring and reporting to the Safety and Data Monitoring Committee. Data will be received, processed and managed on the Data Center system of IBM microcomputers and mainframe VAX. The trial will compare treatment strategies for endophthalmitis and as such "intention to treat" will be primary method of analysis. Analysis methods will be developed and tested during data acquisition phases and final analysis and reports will be generated during the last phase.
| Project Number : | 5U10EY008151-03 |
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| ICD : | NATIONAL EYE INSTITUTE |
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| IRG : | VSN |
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| Project Terms : | antibiotic, refractive keratoplasty, uveitis anterior chamber, cataract surgery, clinical study /trial, cooperative study, drug administration route, eye pharmacology, injection, longitudinal human study, postoperative complication human clinical subject |
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ENDOPHTHALMITIS VITRECTOMY STUDY COORDINATING CENTER
(1994)
Abstract :
The Endophthalmitis Vitrectomy Study (EVS) is a prospective, randomized, multicenter clinical trial designed to determine the role of pars plana vitrectomy in the initial management of patients with bacterial endophthalmitis. This is an application to serve as Coordinating Center for this study, with primary responsibility for study organization, data management and statistical analysis. The accompanying Study chair application presents the study protocol and includes as appendices the manual operation and data collection forms. Investigators from the Epidemiology Data Center at the University of Pittsburgh propose to continue to work with the Study Chair and other clinical investigators to make final revisions to study protocol, manual of operations and data collection forms. The Coordinating Center will be responsible for preparing the randomized scheme, interim monitoring and reporting to the Safety and Data Monitoring Committee. Data will be received, processed and managed on the Data Center system of IBM microcomputers and mainframe VAX. The trial will compare treatment strategies for endophthalmitis and as such "intention to treat" will be primary method of analysis. Analysis methods will be developed and tested during data acquisition phases and final analysis and reports will be generated during the last phase.
| Project Number : | 5U10EY008151-04 |
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| ICD : | NATIONAL EYE INSTITUTE |
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| IRG : | VSN |
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| Project Terms : | antibiotic, refractive keratoplasty, uveitis anterior chamber, cataract surgery, clinical study /trial, cooperative study, drug administration route, eye pharmacology, injection, longitudinal human study, postoperative complication human clinical subject |
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