Interventional Recruiting
NCT06141525 on ClinicalTrials.gov
Safety and Efficacy of Remote Ischemic Conditioning for Patients Taking Off-pump Coronary Artery Bypass Grafting
Official title: Safety and Efficacy of Remote Ischemic Conditioning for Patients Taking Off-pump Coronary Artery Bypass Grafting (IMPROVE): A National, Multi-center, Randomized, Controlled, Open-label, Blinded-endpoint Trial
- Sponsor: First Affiliated Hospital of Xi'an Jiaotong University
- Collaborators: Beijing Anzhen Hospital, People's Hospital of Qinghai Province, The Second Hospital of Yulin City, Baoji Central Hospital
- Enrollment: 648 (Estimated)
- Study start: 2023-11-22 (Actual)
- Primary completion: 2028-12-31 (Estimated)
- Study completion: 2029-03-31 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- Masking: None
- PrimaryPurpose: Supportive Care
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.
Conditions
- Coronary Artery Bypass Grafting
- Remote Ischemic Conditioning
- Ischemia-Reperfusion Injury
Intervention / Treatment
- Device: Remote ischemic conditioning
Primary Outcome Measures
-
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.
Countries
China
Locations and Investigators
-
First Affiliated Hospital of Xi'an Jiantong University, Xi'an, China (Recruiting)
- Guoliang Li
- Yang Yan
Study Officials
- Yang Yan (Principal Investigator) — First Affiliated Hospital Xi'an Jiaotong University