Long-term Remote Ischemic Preconditioning Improves Myocardial Perfusion and Prognosis of Patients After Coronary Artery Bypass Grafting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Change of MPR by SPECT
研究概览
简要总结
Remote Ischemic preconditioning (RIPC) has been reported to improve myocardial microcirculation, promote collateral circulation recruitment, and improve myocardial perfusion in patients.Two large randomized controlled trials demonstrated a perioperative cardioprotective effect of RIPC (reduced troponin levels), but did not find that a single preoperative RIPC improved long-term outcomes of coronary artery bypass grafting(CABG).The effect of a single RIPC before CABG may be too short. This study aims to investigate whether long-term RIPC improved myocardial perfusion in patients 3 months and 6 months after CABG surgery , and to detect changes in blood vascular endothelial growth factor, Nitrc Oxide, adenosine，and Endothelin-1, and to observe MACCE event rates at 12 months.
详细描述
A total of 210 patients were randomly divided into three groups according to the inclusion and exclusion criteria, with 70 patients in each group.
Experimental Group 1:
The patient underwent one RIPC (Four five-minute cycles of upper limb ischaemia and Four five-minute pauses using a blood pressure cuff air vehicle to 200 mmHg) 1 hours before surgery, then normal surgery, and RIPC was performed on the second day after surgery and every day after surgery, which lasted for 1 year.
Experiment Group 2:
Patients underwent once RIPC 1 hours before surgery, and then normal medical procedures were performed with no additional intervention.
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
- None
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
- •Three coronary artery lesions, CABG surgery was planned
排除标准
- •The patients could not tolerate ripc;
- •peripheral vascular disease affecting upper limbs
- •Acute myocardial infarction complicated with cardiogenic shock，in recent 30 days,
- •Emergency cases
- •Severe structural heart disease and severe arrhythmia ；
- •The uncontrolled systolic blood pressure and diastolic blood pressure of severe hypertension were 180 mmHg and 120 mmHg respectively;
- •Severe liver, renal and pulmonary disease
- •Mental disorder can't cooperate;
- •Inability to give informed consent；
- •Patients on glibenclamide or nicorandil, as these medications may interfere with RIC
- •pregnant;
结局指标
主要结局
Change of MPR by SPECT
时间窗: 3 months
Myocardial perfusion was evaluated by Single Photon Emission Computed Tomography(SPECT): myocardial perfusion reserve(MPR)
Change of MBF by CE
时间窗: 3 months
Myocardial perfusion was evaluated by contrast echocardiography(CE): myocardial blood flow(MBF)
Change of MBF by SPECT
时间窗: 3 months
Myocardial perfusion was evaluated by Single Photon Emission Computed Tomography(SPECT): myocardial blood flow(MBF)
Change of MPR by CE
时间窗: 3 months
Myocardial perfusion was evaluated by contrast echocardiography(CE): myocardial perfusion reserve(MPR)
次要结局
- Concentration of ET-1(-1days，1 weeks，3months post surgery)
- MBF by SPECT(1 weeks)
- MPR by CE(1 weeks)
- Rate of major adverse cardiovascular and cerebrovascular events(6 months)
- Change of LVEF by SPECT(1 weeks, 3 months,6 months)
- Concentration of NO(-1days，1 weeks，3months post surgery)
- Seattle angina questionnaire score(1 weeks, 3/6/9 and 12 months post surgery)
- MBF by CE(1 weeks)
- Concentration of BK(-1days，1 weeks，3months post surgery)
- Concentration of adenosine(-1days，1 weeks，3months post surgery)
- 6 minute Walk Test(1 weeks, 3/6/9 and 12 months post surgery)
- MPR by SPECT(1 weeks)
- Concentration of VEGF(-1days，1 weeks，3months post surgery)
- Concentration of troponin(Before surgery and after surgery)