Safety and Efficacy of Remote Ischemic Conditioning for Patients Taking Off-pump Coronary Artery Bypass Grafting (IMPROVE)

Xi'an Jiaotong University

Status: Enrolling

Conditions: Ischemia-Reperfusion Injury; Remote Ischemic Conditioning; Coronary Artery Bypass Grafting

Treatments: Device: Remote ischemic conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT06141525

XJTU1AF2022LSK-427-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 648 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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648 participants in 2 patient groups

RIC group

Experimental group

Description:

In the RIC group, patients will undergo RIC training in the 3 days before and 7 days after the CABG surgery.

Treatment:

Device: Remote ischemic conditioning

Control group

No Intervention group

Description:

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.