Arrested Versus Beating Heart Techniques in Coronary Revascularisation: Randomized Clinical Trial in Unselected Patients
试验速览
- 阶段
- 3 期
- 入组人数
- 616
- 试验地点
- 4
- 主要终点
- Stroke
研究概览
简要总结
The individual contribution of the specific injuring mechanisms surgical trauma, extracorporeal circulation, and ischemia/reperfusion to clinical outcome in coronary revascularisation remains to be elucidated. The effect of these factors is analyzed in this randomized clinical trial by comparing the 3 surgical approaches: Conventional Coronary Artery Bypass Grafting (CCAB), with extracorporeal circulation and cardioplegic arrest; Off-Pump Coronary Artery Bypass Grafting (OPCAB), avoids extracorporeal circulation and global myocardial ischemia; and Pump-Assisted Coronary Artery Bypass Grafting (PACAB), with an unloaded and beating heart. The hypothesis addressed by the study is that the surgical invasiveness increases in the order: OPCAB, PACAB, CCAB.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with double- or triple-vessel coronary artery disease
- •patients with left ventricular ejection fraction =< 40% or >= 60%
- •elective or urgent isolated coronary artery bypass grafting
排除标准
- •previous cardiac surgery
- •emergency indications
结局指标
主要结局
Stroke
时间窗: 1, 6, 12, 24, 48 month
Low-output syndrome
时间窗: in hospital
Myocardial infarction
时间窗: 1, 6, 12, 24, 48 month
New requirement of hemodialysis
时间窗: in hospital
duration of ventilation >= 24h
时间窗: in hospital
All cause mortality
时间窗: 1, 6, 12, 24, 48 month
次要结局
- Resource use (operative time, duration of stay in the intensive care unit, total hospital stay)(in hospital)
- Completeness of revascularization(in hospital)
- Re-revascularization of the target vessel (PCI and/or CABG)(1, 6, 12, 24, 48 month)