Status:
RECRUITING
Safety and Efficacy of Remote Ischemic Conditioning for Patients Taking Off-pump Coronary Artery Bypass Grafting
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Collaborating Sponsors:
Beijing Anzhen Hospital
People's Hospital of Qinghai Province
Conditions:
Coronary Artery Bypass Grafting
Remote Ischemic Conditioning
Eligibility:
All Genders
18-70 years
Phase:
NA
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 64...
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 patient...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2029
Estimated Enrollment :
648 Patients enrolled
Trial Details
Trial ID
NCT06141525
Start Date
November 22 2023
End Date
March 31 2029
Last Update
July 12 2024
Active Locations (1)
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1
First Affiliated Hospital of Xi'an Jiantong University
Xi'an, Shaanxi, China, 710061