CTRI/2013/03/003511已完成未知
International Study of Comparative Health Effectiveness with Medical and Invasive Approaches - ISCHEMIA
ew York University School of Medicine0 个研究点目标入组 941 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 941
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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
- •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
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