A Clinical Study on the Effect of Remote Ischemic Conditioning on Atrial Fibrillation and Outcome After Coronary Artery Bypass Grafting
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- Post-operative atrial fibrillation
研究概览
简要总结
Recent studies indicate that remote ischemic conditioning can protect the heart and other organs during cardiac surgery. The investigators aim to investigate whether such a stimulus can reduce the incidence of atrial fibrillation or other complications following coronary artery bypass surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Elective on-pump CABG surgery
- •Informed consent
排除标准
- •Prior cardiac surgery (Re-operations)
- •Prior atrial fibrillation
- •Use of class 1 or 3 anti arrhythmic medication or digoxin Use of intermittent aortic cross clamping during surgery
- •Age <18 years
- •Left ventricular ejection fraction ≤30%
- •Serious pulmonary disease (resting pO2 <90% at room air)
- •Renal failure (clearance <30 ml/min as calculated using the Modification of Diet in Renal Disease formula)
- •Liver failure
- •Use of the sulfonylurea derivative glibenclamide (this drug is known to block any preconditioning stimulus
研究组 & 干预措施
Preconditioning
The remote ischemic stimulus will be applied after induction of anaesthesia, but before cardiopulmonary bypass.
干预措施: Remote ischemic conditioning (Procedure)
Postconditioning
The remote ischemic stimulus during cardiopulmonary bypass.
干预措施: Remote ischemic conditioning (Procedure)
Pre and postconditioning
The remote ischemic stimulus will be applied twice, after induction of anaesthesia and during cardiopulmonary bypass.
干预措施: Remote ischemic conditioning (Procedure)
Control
干预措施: Sham (Procedure)
结局指标
主要结局
Post-operative atrial fibrillation
时间窗: 72 hours
次要结局
- Major cardiovascular and cerebrovascular events(3 months, 6 months, 1 year)
- Length of stay(1 week on avarage)
研究者
B Preckel
Prof. dr. B. Preckel
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)