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

Not Applicable

Recruiting

• Conditions: Coronary Artery Bypass Grafting; Remote Ischemic Conditioning; Ischemia-Reperfusion Injury
• Interventions: Device: Remote ischemic conditioning

• Registration Number: NCT06141525
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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 Timeline

• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-15
• Study First Posted: 2023-11-21
• Study Start: 2023-11-22
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12
• Primary Completion: 2028-12-31
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 648

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIC group	Remote ischemic conditioning	In the RIC group, patients will undergo RIC training in the 3 days before and 7 days after the CABG surgery.

Primary Outcome Measures

Name	Time	Method
The incidence of MACCE	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 Outcome Measures

Name	Time	Method
The total length of stay in the hospital	About 7days after the operation.	This outcome includes all days in the hospital of all patients. The data will be recorded from the medical records.
The incidence of all-cause of death	3-month after the enrollment.	The data will be obtained at 3-month follow-up, according to medical records of all patients.
The incidence of myocardial infarction	3-month after the enrollment.	The data will be obtained at 3-month follow-up, according to medical records of all patients.
The incidence of stroke	3-month after the enrollment.	The data will be obtained at 3-month follow-up, according to medical records of all patients.
Changes of 6-min walk test results	3-month after the enrollment.	6-min walk test will be measured by stopwatches and metre rulers. The test assesses the overall response of all systems involved in exercise by measuring the distance the patient walks rapidly on a flat, hard surface over a period of six minutes.
The incidence of coronary revascularization surgery	3-month after the enrollment.	The data will be obtained at 3-month follow-up, according to medical records of all patients.
The length of postoperative ICU-stay	About 3 days after the operation.	This outcome includes all days in ICU after the operation of all patients. The data will be recorded from the medical records.

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiantong University; 🇨🇳 Xi'an, Shaanxi, China