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

Launched by FIRST AFFILIATED HOSPITAL XI'AN JIAOTONG UNIVERSITY · Nov 15, 2023

Keywords

ClinConnect Summary

This clinical trial, called the IMPROVE trial, is studying a method known as Remote Ischemic Conditioning (RIC) to see if it can improve the health outcomes of patients undergoing off-pump coronary artery bypass grafting (CABG). RIC involves briefly restricting blood flow to certain areas of the body and then restoring it, which has been shown to help protect vital organs during surgery. The trial aims to enroll 648 patients with coronary artery disease in five centers across China to determine if this technique can lead to better recovery and overall results after surgery.

To participate in this trial, you need to be between 18 and 75 years old, diagnosed with coronary artery disease, and scheduled for off-pump CABG surgery. You should also have a good heart function, with no severe heart valve issues. If you join the trial, you will be asked to give your consent and will receive RIC alongside your usual care during the surgery. It’s important to note that individuals with certain health conditions, such as severe heart failure or serious injuries, cannot participate. If you or a loved one is considering this trial, it could offer a chance to contribute to important research while receiving potentially beneficial care.

Gender

ALL

Eligibility criteria

• 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.