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

Recruiting now · Not applicable

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

In brief

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.

Key facts

Study ID

NCT06141525

Run by

First Affiliated Hospital Xi'an Jiaotong University

People needed

648

Starts

2023-11-22

Expected to finish

2029-03-31

Last updated by the study team

2024-07-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• First Affiliated Hospital of Xi'an Jiantong University — Xi'an, Shaanxi, China (enrolling)

Full record on ClinicalTrials.gov

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