CTRI/2013/03/003511已完成不适用
International Study of Comparative Health Effectiveness with Medical and Invasive Approaches
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8,000
- 试验地点
- 20
- 主要终点
- Time to first occurrence of cardiovascular death or nonfatal myocardial infarction
研究概览
简要总结
The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease. This is a multicenter randomized controlled trial with a target enrollment of ~8000 patients with at least moderate ischemia on stress imaging. Patients will be assigned at random to a routine invasive strategy (INV) with cardiac catheterization (cath) followed by revascularization plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cath and revascularization reserved for those with an acute coronary syndrome, ischemic heart failure, resuscitated cardiac arrest or refractory symptoms
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 21.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Participant is willing to give written informed consent Age ≥ 21 years At least moderate ischemia on a stress imaging test with nuclear myocardial perfusion.
排除标准
- •LVEF 35% History of unprotected left main stenosis 50% on prior coronary computed tomography angiography (CCTA) or prior cardiac catheterization (if available).
- •Finding of "no obstructive CAD" (50% stenosis in all major epicardial vessels) on prior CCTA or prior catheterization, performed within 12 months Prior known coronary anatomy unsuitable for either PCI or CABG Unacceptable level of angina despite maximal medical therapy Very dissatisfied with medical management of angina History of noncompliance with medical therapy Acute coronary syndrome within the previous 2 months PCI or CABG within the previous 12 months Stroke within the previous 6 months or intracranial hemorrhage at any time History of ventricular tachycardia requiring therapy for termination, or symptomatic sustained ventricular tachycardia NYHA class III-IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months Non-ischemic dilated or hypertrophic cardiomyopathy End stage renal disease on dialysis or estimated glomerular filtration rate (eGFR) 30mL/min Severe valvular disease or valvular disease likely to require surgery within 5 years Allergy to radiographic contrast that cannot be adequately pre-medicated, or any prior anaphylaxis to radiographic contrast Planned major surgery necessitating interruption of dual antiplatelet therapy Life expectancy less than 5 years due to non-cardiovascular comorbidity Pregnancy (known to be pregnant; to be confirmed before CCTA and/or randomization, if applicable) Enrolled in a competing trial that involves a non-approved cardiac drug or device Inability to comply with the protocol Exceeds the weight or size limits for CCTA or cardiac catheterization at the enrolling site.
结局指标
主要结局
Time to first occurrence of cardiovascular death or nonfatal myocardial infarction
时间窗: Four year follow up
次要结局
- ngina control per Seattle Angina Questionnaire (SAQ) Angina Frequency Scale(Four year follow up)
- Stroke(Four year follow upv)
- Hospitalization for heart failure(Four year follow up)
- Health resource utilization, costs, and cost effectiveness(Four year follow up)
- Cardiovascular death(Four year follow up)
- Nonfatal myocardial infarction(Four year follow up)
- Resuscitated cardiac arrest(Four year follow up)
- Hospitalization for unstable angina(Four year follow up)
- Composite of cardiovascular death, nonfatal myocardial infarction, stroke, resuscitated cardiac arrest, hospitalization for unstable angina or heart failure(Four year follow up)
- Disease specific quality of life per Seattle Angina Questionnaire (SAQ) Quality of Life Scale(Four year follow up)
- Composite of cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure(Four year follow up)
研究者
研究点 (20)
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