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The ISCHEMIA Trial - SDCC

缺血试验 - SDCC

基本信息

批准号：
8424978
负责人：
KAREN P ALEXANDER
金额：
$ 208.57万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-07-22 至 2018-10-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8424978
关键词：
Address Anatomy Angiography Blinded Bypass Cardiac Cardiac Catheterization Procedures Cardiovascular system Caring Catheterization Cause of Death Cessation of life Clinical Clinical Data Clinical Trials Clinical Trials Data Monitoring Committees Collaborations Collection Companions Comparative Study Computers Coronary Coronary Arteriosclerosis Coronary Artery Bypass Coronary artery Data Data Collection Data Coordinating Center Disease Dose Economics Effectiveness Eligibility Determination Enrollment Event Frequencies Genetic Crossing Over Goals Guidelines Health Health Resources Heart Arrest Heart failure Hospitalization Image Incidence Intention International Ischemia Leadership Left Left Ventricular Ejection Fraction Life Style Medical Monitor Myocardial Myocardial Infarction Myocardial Ischemia National Heart, Lung, and Blood Institute Operative Surgical Procedures Outcome Patients Pharmaceutical Preparations Phase Policies Preparation Procedures Process Publications Qualifying Quality Control Quality of life Questionnaires Randomized Randomized Controlled Trials Recruitment Activity Reporting Research Design Risk Role Selection Bias Severities Site Stents Stress Stress Tests Stroke Summary Reports Surgeon Symptoms System Testing Time Training Unstable angina Work abstracting acute coronary syndrome base comparative effectiveness cost cost effectiveness data integrity data management data sharing effectiveness research electronic data follow-up improved meetings percutaneous coronary intervention prevent prospective protocol development tool

项目摘要

DESCRIPTION (provided by applicant): The long-term objective of the proposed trial, International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA), is to define the role of an invasive approach in patients with stable ischemic heart disease (SIHD) and substantial ischemia. The trial hypothesis is that cardiac catheterization followed by complete revascularization plus optimal medical therapy (OMT) is superior to OMT alone as the management strategy for patients with moderate-severe ischemia on stress imaging. The primary endpoint will be time to cardiovascular death, myocardial infarction (MI), or hospitalization for unstable angina, resuscitated cardiac arrest, or heart failure. The hypothesis that the invasive strategy will improve quality of life will also be tested. Cost-effectiveness will be assessed. The COURAGE and BARI 2D trials found that an initial management strategy of coronary revascularization did not reduce the risk of death or MI compared with OMT alone in SIHD patients selected on the basis of coronary anatomy. These data raise the question whether cardiac catheterization (cath) is required in stable patients. Cath in such patients usually leads to revascularization. Although COURAGE and BARI 2D included a broad range of severity of myocardial ischemia on stress testing, most patients had mild-moderate ischemia. Observational data suggest that revascularization of patients with moderate-severe ischemia is associated with a lower likelihood of death and MI; this is not observed in patients with lesser degrees of ischemia. Only about half of patients with moderate-severe ischemia are referred for cath. It is unknown whether use rates for cath and revascularization are appropriate for optimal patient management in the era of modern medical therapy (particularly with high dose statins and antiplatelet therapy). This issue cannot be resolved using available data because prior clinical trials in SIHD have enrolled patients after cath, at which point there is substantial selection bias for enrollment based on coronary anatomy. Given the potential for improved survival and fewer cardiac events as a result of revascularization and the significant expense and risks associated with invasive management, the role of an invasive strategy is critically important to define. Defining that role is among the top 100 US priorities for comparative effectiveness research. The proposed ISCHEMIA trial will be a prospective, multicenter, international, randomized, controlled trial that will directly address the need for an invasive strategy-cath and revascularization-in patients with SIHD. A total of 8,000 patients with moderate-severe ischemia and left ventricular ejection fraction >35% will be enrolled after stress imaging from more than 400 sites. Based on the need to exclude significant left main coronary artery disease, patients who meet eligibility criteria will undergo blinded coronary CT angiography. Patients will be randomized to an invasive group that will undergo routine cath with optimal revascularization, if feasible, plus OMT or to a group that receives OMT alone.

描述（由申请人提供）：