The ISCHEMIA Trial - IICC

缺血试验 - IICC

• 批准号: 8027420
• 负责人: Leslee J Shaw
• 金额: $ 12.43万
• 依托单位: EMORY 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/8027420
• 关键词: Address; Adherence; Anatomy; Angiography; Blinded; Bypass; Cardiac; Cardiac Catheterization Procedures; Cardiovascular system; Caring; Catheterization; Cessation of life; Clinical; Clinical Trials; Comparative Study; Continuing Education; Coronary; Coronary Arteriosclerosis; Coronary artery; Coupled; Data; Data Collection; Diagnostic; Dose; Drug Evaluation; Echocardiography; Education; Effectiveness; Eligibility Determination; Enrollment; Ensure; Event; Exhibits; Feedback; Frequencies; Health; Heart Arrest; Heart failure; Hospitalization; Image; Incidence; Intention; International; Ischemia; Left; Left Ventricular Ejection Fraction; Life Style; Link; Magnetic Resonance; Manuals; Measures; Medical; Monitor; Myocardial Infarction; Myocardial Ischemia; Myocardial perfusion; Nuclear; Operative Surgical Procedures; Outcome; Patients; Performance; Perfusion; Pharmaceutical Preparations; Physicians; Positron-Emission Tomography; Process; Protocols documentation; Quality Control; Quality of life; Randomized; Randomized Controlled Trials; Reader; Reporting; Risk; Role; Selection Bias; Severities; Site; Stents; Stress; Stress Echocardiography; Stress Tests; Symptoms; Testing; Time; Unstable angina; Validity of Results; abstracting; base; comparative effectiveness; cost effectiveness; effectiveness research; experience; follow-up; high standard; improved; inclusion criteria; meetings; operation; performance site; performance tests; prevent; prospective; single photon emission computed tomography

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. 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 invasive 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 with stents or surgery if symptoms cannot be controlled? If there is a benefit to doing an angiogram and treating with stents or surgery, 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）： 拟议试验的长期目标是药物和侵入性方法的健康有效性比较国际研究 (ISCHEMIA)，其长期目标是确定侵入性方法在稳定型缺血性心脏病 (SIHD) 和严重缺血患者中的作用。试验假设是，心导管插入术后完全血运重建加最佳药物治疗 (OMT) 作为应力成像中重度缺血患者的治疗策略优于单独使用 OMT。主要终点是心血管死亡、心肌梗塞 (MI) 或因不稳定心绞痛、复苏性心脏骤停或心力衰竭住院的时间。侵入性策略将改善生活质量的假设也将得到检验。将评估成本效益。 COURAGE 和 BARI 2D 试验发现，对于根据冠状动脉解剖选择的 SIHD 患者，与单独使用 OMT 相比，冠状动脉血运重建的初始管理策略并不能降低死亡或心肌梗死的风险。这些数据提出了一个问题：稳定的患者是否需要心导管术（cath）。此类患者的导管通常会导致血运重建。尽管 COURAGE 和 BARI 2D 在压力测试中包含了广泛的心肌缺血严重程度，但大多数患者患有轻度至中度缺血。观察数据表明，中重度缺血患者的血运重建与较低的死亡和心肌梗死可能性相关；在缺血程度较轻的患者中没有观察到这一点。只有大约一半的中重度缺血患者被转诊接受导管治疗。目前尚不清楚导管和血运重建的使用率是否适合现代医学治疗时代的最佳患者管理（特别是高剂量他汀类药物和抗血小板治疗）。使用现有数据无法解决这个问题，因为之前的 SIHD 临床试验都是在导管术后入组患者，此时基于冠状动脉解剖的入组存在很大的选择偏差。考虑到血运重建可能提高生存率并减少心脏事件，以及与侵入性治疗相关的巨大费用和风险，确定侵入性策略的作用至关重要。界定这一角色是美国比较有效性研究的 100 项优先事项之一。 拟议的 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（导管和血运重建）的需求。共有 8,000 名中重度缺血且左心室射血分数 >35% 的患者将在 400 多个地点进行应力成像后入组。基于排除显着的左主干冠状动脉疾病的需要，符合资格标准的患者将接受盲法冠状动脉CT血管造影。患者将被随机分配到侵入性组，该组将接受常规导管治疗和最佳血运重建（如果可行）加 OMT，或分配到单独接受 OMT 的组。 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：当患者的心脏负荷测试中度至严重异常时，是否最好进行侵入性血管造影（拍摄心脏动脉的照片）？打算通过支架或手术加最佳的药物治疗来打开或绕过任何阻塞，或者如果症状无法控制，最好优化药物治疗并仅考虑支架或手术的血管造影？如果进行血管造影以及支架或手术治疗有好处，那么临床医生和患者必须意识到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后果；如果结果显示常规侵入性检测没有任何益处，那么治疗将仅从强化生活方式改变和药物控制症状和降低风险开始。这两项发现都可以提供急需的信息来指导实践和提高医疗质量。 （摘要完）