The ISCHEMIA Trial - EQOL

缺血试验 - EQOL

• 批准号: 8424993
• 负责人: Daniel B Mark
• 金额: $ 34.38万
• 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 2017-10-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8424993
• 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.

描述（由申请人提供）： 这项名为“国际医疗和侵入性方法（ISCHEMIA）健康效果比较研究”的拟议试验的长期目标是确定侵入性方法在稳定性缺血性心脏病（SIHD）患者中的作用。试验假设是，心脏导管插入术后完全血运重建加最佳药物治疗（OMT）上级OMT单独作为负荷成像显示中重度缺血患者的初始管理策略。主要终点为至心血管死亡、心肌梗死（MI）或因急性心脏事件（不稳定型心绞痛、心脏骤停复苏或心力衰竭）住院的时间。我们还将检验侵入性策略将改善生活质量的假设。将评估成本效益。 COUHD和巴里-2D试验发现，当根据冠状动脉解剖结构选择患者时，与单独OMT相比，SIHD中冠状动脉血运重建的初始管理策略并未降低死亡或MI的风险。这些数据提示推断，稳定的患者可能不需要心导管插入术（cath）。导管在这类患者中通常导致血运重建。COURAGE和巴里-2D包括激发试验中广泛的心肌缺血严重程度;大多数患者有轻度-中度缺血。然而，观察数据表明，血运重建与中重度缺血患者的死亡和MI可能性较低相关，但与缺血程度较轻的患者无关。只有大约一半的中重度缺血患者被转诊接受导管插入术。在现代医学治疗（高剂量他汀类药物和抗血小板治疗）时代，导管插入术和血运重建术的使用率是否适用于最佳患者管理尚不清楚。使用现有数据无法解决该问题，因为SIHD的既往临床试验已入组导管插入后患者，此时基于解剖结构的入组存在大量选择偏倚。考虑到血运重建可能延长生命和避免不良临床心脏事件，以及与侵入性管理相关的重大费用和风险，定义侵入性策略的作用至关重要。 拟定的ISCHEMIA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患者对侵入性策略、导管插入和血运重建的需求。我们计划从400-500个中心招募约8，000名中重度缺血且左心室射血分数>35%的患者，这些患者在负荷成像后招募。符合合格标准的患者将接受设盲冠状动脉CT血管造影，以排除严重的左主干冠状动脉疾病和非阻塞性疾病。随机分配至侵入性组的患者将按照研究指南进行最佳血运重建。