The ISCHEMIA Trial - EQOL

缺血试验 - EQOL

• 批准号: 8027079
• 负责人: Daniel B Mark
• 金额: $ 10.09万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-22 至 2017-08-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8027079
• 关键词: Acute; Address; Anatomy; Angiography; Blinded; Bypass; Cardiac; Cardiac Catheterization Procedures; Cardiovascular system; Caring; Catheterization; Cessation of life; Clinical; Clinical Trials; Companions; Comparative Study; Coronary; Coronary Arteriosclerosis; Coronary Artery Bypass; Coronary artery; Data; Data Coordinating Center; Disease; Dose; Economics; Effectiveness; Eligibility Determination; Enrollment; Event; Exclusion; Goals; Guidelines; Health; Heart Arrest; Heart failure; Hospitalization; Image; Intention; International; Intervention; Ischemia; Left; Left Ventricular Ejection Fraction; Life; Life Extension; Life Style; Medical; Myocardial Infarction; Myocardial Ischemia; Operative Surgical Procedures; Outcome; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Quality of life; Quality-Adjusted Life Years; Randomized; Randomized Controlled Trials; Recruitment Activity; Relative (related person); Risk; Role; Secondary Prevention; Selection Bias; Severities; Site; Stents; Stress; Stress Tests; Symptoms; Testing; Time; Unstable angina; abstracting; base; cost; cost effectiveness; disorder control; health related quality of life; improved; meetings; percutaneous coronary intervention; prevent; prospective; treatment strategy

DESCRIPTION (provided by applicant): The long-term objective of the proposed trial, entitled 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). The trial hypothesis is that cardiac catheterization followed by complete revascularization plus optimal medical therapy (OMT) is superior to OMT alone as the strategy for initial management of patients with moderate-to-severe ischemia on stress imaging. The primary endpoint will be time to cardiovascular death, myocardial infarction (MI), or hospitalization for an acute cardiac event (unstable angina, resuscitated cardiac arrest, or heart failure). We will also test the hypothesis that the invasive strategy will improve quality of life. 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 in SIHD compared with OMT alone when patients were selected based on coronary anatomy. These data have prompted inference that cardiac catheterization (cath) may not be required in stable patients. Cath in such patients usually leads to revascularization. COURAGE and BARI-2D included a broad range of severity of myocardial ischemia on provocative testing; most patients had mild-moderate ischemia. However, observational data suggest that revascularization is associated with a lower likelihood of death and MI in patients with moderate-severe ischemia but not 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 (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 anatomy. Given the potential for extension of life and avoidance of adverse clinical 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. 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. We plan to enroll approximately 8,000 patients from among 400-500 sites with moderate-severe ischemia and left ventricular ejection fraction >35% who are recruited after stress imaging. Patients who meet eligibility criteria will undergo blinded coronary CT angiography to exclude significant left main coronary artery disease and nonobstructive disease. Patients randomized to the invasive group will undergo optimal revascularization following study guidelines. Project Narrative: This trial will inform clinicians and patients about a very common question they encounter: when a patient has a moderately to severely abnormal cardiac stress test, is it better to do an angiogram (take a picture of the heart arteries) with the intention of opening or bypassing any blockages with stents or surgery plus optimal medical therapy, or is it better to optimize medical therapy and only consider the angiogram if symptoms cannot be controlled? If there is a benefit to invasive testing and treatment, then clinicians and patients must be made aware of these benefits and put them into practice to prevent bad outcomes like heart attacks and death; if the results show there is no benefit from routine invasive testing, then treatment would begin with only intensive lifestyle change and medication to control symptoms and reduce risk. Either finding could provide much-needed information to guide practice and improve quality of medical care. (End of Abstract)

描述（由申请人提供）： 该拟议试验的长期目标是针对医学和侵入性方法的比较健康有效性的国际研究（缺血），是为了确定侵入性方法在稳定缺血性心脏病（SIHD）患者中的作用。试验假设是心脏导管插入术，然后完全血运重建加最佳药物治疗（OMT）优于OMT，因为在压力成像中，中度至重度缺血患者的初始管理策略。主要的终点是急性心脏事件的心血管死亡，心肌梗塞（MI）或住院治疗的时间（不稳定的心绞痛，复苏心脏骤停或心力衰竭）。我们还将检验以下假设：侵入性策略将改善生活质量。成本效益将被评估。 勇气和BARI-2D试验发现，与单独选择患者基于冠状动脉解剖结构相比，与单独选择患者相比，冠状动脉血运重建的初始管理策略并不能降低SIHD死亡或MI的风险。这些数据促使人们推断了稳定患者可能不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。 Courage和Bari-2D包括在挑衅性测试中的心肌缺血的广泛严重程度；大多数患者患有温和的缺血。但是，观察数据表明，中度重度缺血患者的死亡和MI可能性较低，而缺血程度较低的患者无关。 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（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。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。鉴于由于血运重建而延长生命并避免不良临床心脏事件，以及与侵入性管理相关的巨大费用和风险，因此侵入性策略的作用对于定义至关重要。 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SIHD患者的侵入性策略，CATH和血运重建的需求。我们计划从400-500名中等重度缺血的部位和左心室射血分数中招募约8,000名患者，> 35％，他们在压力成像后被招募。符合资格标准的患者将经历盲人CT血管造影，以排除重要的左主冠状动脉疾病和非刺激性疾病。根据研究指南，随机分配给入侵组的患者将经历最佳的血运重建。 项目叙述：该试验将告知临床医生和患者他们遇到的一个非常常见的问题：当患者患有中度至严重异常的心脏压力测试时，更好地进行血管造影（为心脏动脉的照片），目的是打开或绕开任何障碍，或者是无法进行的，或者仅考虑到最佳的医疗疗法，或者是绕开任何障碍吗？如果侵入性测试和治疗有好处，则必须使临床医生和患者了解这些好处，并将其付诸实践，以防止心脏病发作和死亡等不良结果；如果结果表明常规侵入性测试没有任何好处，那么治疗将仅从强化的生活方式改变和药物来控制症状并降低风险开始。两种发现都可以提供急需的信息，以指导实践并提高医疗质量。 （抽象的结尾）