The ISCHEMIA Trial - SDCC

缺血试验 - SDCC

基本信息

批准号：
8306079
负责人：
KAREN P ALEXANDER
金额：
$ 393.39万
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 2019-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8306079
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）：拟议试验的长期目标是，国际对医学和侵入性方法的比较健康有效性（缺血）的研究是确定侵入性方法在稳定缺血性心脏病（SIHD）和实质性缺血患者中的作用。试验假设是心脏导管插入术，然后是完全血运重建加最佳药物治疗（OMT），它仅优于OMT，作为对压力成像中中度严重缺血的患者的管理策略。主要终点是该是心血管死亡，心肌梗死（MI）或住院不稳定的心绞痛，复苏心脏骤停或心力衰竭的时候了。侵入性策略将改善生活质量的假设也将得到测试。成本效益将被评估。勇气和BARI 2D试验发现，与单独的SIHD患者相比，根据冠状动脉解剖结构选择的SIHD患者，冠状动脉血运重建的初始管理策略并没有降低死亡或MI的风险。这些数据引发了一个问题，是否需要稳定的患者需要心脏导管插入术（CATH）。此类患者的CATH通常会导致血运重建。尽管Courage和Bari 2d在压力测试中包括多种心肌缺血的严重程度，但大多数患者患有轻度 - 中度缺血。观察数据表明，中等重度缺血患者的血运重建与死亡和MI的可能性较低有关。在缺血程度较低的患者中未观察到这一点。 CATH中只有大约一半的中性缺血患者被转诊为CATH。在现代医疗治疗时代（尤其是使用高剂量汀类药物和抗血小板疗法），CATH和血运重建的使用率是否适合最佳患者管理，这是尚不清楚的。无法使用可用数据解决此问题，因为SIHD的先前临床试验已在CATH之后招募患者，此时，基于冠状动脉解剖结构的入学率存在很大的选择偏见。鉴于由于血运重建以及与侵入性管理相关的巨大费用和风险的可能性提高了生存的潜力和更少的心脏事件，因此侵入性策略的作用对于定义至关重要。定义该角色是比较有效性研究的美国100个优先事项之一。拟议的缺血试验将是一项前瞻性，多中心，国际，随机，对照试验，将直接解决对SIHD的侵入性策略考验和血管造成的患者的需求。在400多个部位的压力成像后，将招募8,000名中度重度缺血和左心室射血分数的患者> 35％。根据需要排除重要左主冠状动脉疾病的必要性，符合资格标准的患者将接受盲目的冠状动脉血管造影。患者将被随机分为一个侵入性组，该组将经历常规的CATA，以最佳的血运重建（如果可行），以及OMT或单独接受OMT的组。