Safety and Efficacy of Remote Ischemic Conditioning for Patients Taking Off-pump Coronary Artery Bypass Grafting (IMPROVE): A National, Multi-center, Randomized, Controlled, Open-label, Blinded-endpoint Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 648
- 试验地点
- 1
- 主要终点
- The incidence of MACCE
研究概览
简要总结
Remote ischemic conditioning (RIC) is the process of repeated ischemia and reperfusion in the peripheral vessels, which is proved in reducing IRI in vital organs. This IMPROVE trial plans to enroll 648 patients who are diagnosed with coronary artery disease and are going to take off-pump CABG in five centers in China, to access whether RIC can and improve short-term prognosis.
详细描述
Remote ischemic conditioning (RIC) is the process of repeated ischemia and reperfusion in the peripheral vessels, which is proved in reducing IRI in vital organs. However, the effect of RIC in patients undergoing off-pump CABG is still unclear. This IMPROVE trial plans to enroll 648 patients who are diagnosed with coronary artery disease and are going to take off-pump CABG in five centers in China, to access whether RIC can and improve short-term prognosis. Patients will be randomly assigned into RIC group and control group. The primary outcome is the occurrence of the major adverse cardiovascular and cerebrovascular events (MACCE) within the 3-month follow-up. The MACCE is defined as all-cause of death, myocardial infarction, stroke and coronary revascularization surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with coronary artery disease and require off-pump CABG surgery.
- •Between 18 and 75 years old;
- •Normal left ventricular systolic function (ejection fraction >40%) and left ventricular end-diastolic internal diameter (<60 mm) in the cardiac ultrasound tests;
- •No or mild heart valve and great vessel abnormalities which do not require surgical intervention;
- •Participants or their authorized relatives agree to participate in the clinical trial and sign the informed consent.
排除标准
- •Severe tissue injuries.
- •Myalgia, fractures and other peripheral vascular lesions.
- •Bypass graft being the radial artery.
- •Stenosis or severe malformations of the subclavian, jugular and femoral arteries and veins.
- •Previous vagus nerve trunk dissection or vagus nerve block surgery.
- •Other surgical operations at the same time.
- •Patients with pre-existing severe cardiac insufficiency, acute coronary syndromes, malignant hypertension and cardiogenic shock.
- •Severe coagulation abnormality or severe anemia.
- •Severe mental disorder.
- •Malignant tumors.
- •Pregnant or lactating.
- •Increased risk of treatment for patients, according to investigators.
- •Refuse to sign the informed consent form.
研究组 & 干预措施
RIC group
In the RIC group, patients will undergo RIC training in the 3 days before and 7 days after the CABG surgery.
干预措施: Remote ischemic conditioning (Device)
Control group
In the control group, a blood pressure cuff, same as the cuff in the RIC group, will be placed on both upper arms of the patients but only pressurized to 60 mmHg. The rest of the procedures will be the same.
结局指标
主要结局
The incidence of MACCE
时间窗: 3-month after the enrollment.
MACCE includes all-cause of death, myocardial infarction, stroke and coronary revascularization surgery. The data will be obtained at 3-month follow-up, according to medical records of all patients.
次要结局
- The total length of stay in the hospital(About 7days after the operation.)
- The incidence of myocardial infarction(3-month after the enrollment.)
- The incidence of stroke(3-month after the enrollment.)
- Changes of 6-min walk test results(3-month after the enrollment.)
- The incidence of coronary revascularization surgery(3-month after the enrollment.)
- The incidence of all-cause of death(3-month after the enrollment.)
- The length of postoperative ICU-stay(About 3 days after the operation.)