NCT01198405Unknown不适用
A Prospective,Randomized,Open-labeled,and Blind Endpoint Study of Enhanced External Counterpulsation for Patients With Coronary Heart Disease
Sun Yat-sen University4 个研究点 分布在 1 个国家目标入组 1,050 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,050
- 试验地点
- 4
- 主要终点
- composite endpoint of rate of all-cause mortality, revascularization, rehospitalization and acute myocardial infarction
研究概览
简要总结
To investigate the mid- and long-term effect of Enhanced External Counterpulsation combined with guideline-driven standard treatment on patients documented with and/or at high risk of coronary artery disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least one coronary lesion of more than 50% stenosis shown by angiography
- •history of acute myocardial infarction(at least one month before)
- •history of prior revascularization (Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting)
- •typical angina episodes with evidence of myocardial ischemia
- •Signed informed consent
排除标准
- •Obvious aortic insufficiency, aortic aneurysm, aortic dissection
- •Coronary fistula or severe coronary aneurysm
- •Symptomatic Congestive heart failure
- •Valvular heart disease, congenital heart diseases, cardiomyopathies
- •Cerebral hemorrhage within six months, bleeding disorders or identified bleeding tendency;
- •Lower limb infection, phlebitis, varicosity, deep venous thrombosis;
- •Progressive malignancies or diseases with poor prognosis;
- •uncontrolled hypertension, defined as SBP≥180mmHg or DBP≥110mmHg
研究组 & 干预措施
Enhanced External Counterpulsation
Experimental
Treatment of Enhanced External Counterpulsation (EECP) with a prespecified protocol on top of guideline-driven standard medical therapy.
干预措施: Enhanced external counterpulsation (Device)
Control
Active Comparator
Guideline-driven standard medical therapy.
干预措施: Guideline-driven standard medical therapy (Drug)
结局指标
主要结局
composite endpoint of rate of all-cause mortality, revascularization, rehospitalization and acute myocardial infarction
时间窗: up to 5 years
次要结局
- vascular endothelial function(up to 5 years)
- cardiac structure and exercise tolerance(up to 5 years)
- new-onset diabetes(up to 5 years)
- atherosclerosis(up to 5 years)
- 24-hour urinary protein(up to 5 years)
- all-cause mortality(up to 5 years)
- revascularization rate(up to 5 years)
- rehospitalization rate(up to 5 years)
- rate of acute myocardial infarction(up to 5 years)
研究者
研究点 (4)
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