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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 648
- Locations
- 1
- Primary Endpoint
- The incidence of MACCE
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The incidence of MACCE
Time Frame: 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.
Secondary Outcomes
- 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.)