Effects of Remote Ischemic PreConditioning in Off-pump Versus On-pump Coronary
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Perioperative extent of myocardial injury as measured by cardiac troponin T serum release over 72 hours after coronary bypass surgery and its area under the curve (AUC).
研究概览
简要总结
Purpose Remote ischemic preconditioning (RIPC) with transient upper limb ischemia reduces myocardial injury in patients undergoing On-pump coronary artery bypass (CABG) surgery with cross-clamp fibrillation or blood cardioplegia for myocardial protection. The molecular mechanisms leading to these effects are yet not fully understood. The purpose of the present study is to validate previous studies and gather further evidence for RIPC during CABG with blood cardioplegia, furthermore to determine, whether or not RIPC is still operative during Off-pump coronary artery bypass surgery (OPCAB), finally to elucidate intra-cellular mechanisms involved in myocardial protection by RIPC and their possible systemic mediators.
详细描述
Remote ischemic preconditioning (RIPC) protocol before CABG (study arm A) or OPCAB (study arm B) consists of 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 minutes of reperfusion after induction of anesthesia before coronary artery bypass surgery. For myocardial molecular analyses, left ventricular biopsies are taken before induction of cardioplegic cardiac arrest (A) or first coronary incision (B), and 5 to 10 minutes after aortic unclamping during reperfusion of the myocardium (A) or 5 to 10 minutes after the completion of the last anastomosis (B). Blood samples are taken prior to RIPC and during the first three postoperative days.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed triple vessel coronary artery disease
- •Indication for surgical coronary revascularisation
- •Written informed consent
- •Age ≥ 18 years
排除标准
- •Age > 80 years
- •Instable angina/acute coronary syndrome
- •Emergency surgery
- •Recent myocardial infarction within 7 days prior to surgery
- •Recent major infection/sepsis within 7 days prior to surgery
- •Significant hepatic, renal oder pulmonary disease
- •Other concomitant surgical procedures
结局指标
主要结局
Perioperative extent of myocardial injury as measured by cardiac troponin T serum release over 72 hours after coronary bypass surgery and its area under the curve (AUC).
时间窗: 72 hours postoperatively after CABG surgery
次要结局
- All-cause mortality(30 days and 1 year after coronary bypass surgery)
- Major adverse cardiac and cerebrovascular events (MACCE)(30 days and 1 year after coronary bypass surgery)
- Myocardial infarction(30 days and 1 year after coronary bypass surgery)
- Renal function(30 days and 1 year after coronary bypass surgery)
- circulating microparticles after coronary bypass surgery(perioperatively, 3 months and 1 year after coronary bypass surgery)