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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
First Affiliated Hospital of Xi'an Jiantong University
RECRUITING
Xi'an
Contact Information
Primary
Yang Yan
yangyan3@xjtu.edu.cn
+86.29.85323869
Backup
Li Guoliang
liguoliang_med@163.com
+86.29.85323869
Time Frame
Start Date: 2023-11-22
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 648
Treatments
Experimental: RIC group
In the RIC group, patients will undergo RIC training in the 3 days before and 7 days after the CABG surgery.
No_intervention: Control group
In the control group, a blood pressure cuff, same as the cuff in the RIC group, will be placed on both upper arms of the patients but only pressurized to 60 mmHg. The rest of the procedures will be the same.
Sponsors
Collaborators: Baoji Central Hospital, Beijing Anzhen Hospital, The Second Hospital of Yulin City, People's Hospital of Qinghai Province
Leads: First Affiliated Hospital Xi'an Jiaotong University

This content was sourced from clinicaltrials.gov