Using remote ischemic conditioning to improve outcomes for patients undergoing 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
Run by First Affiliated Hospital Xi'an Jiaotong University · NCT06141525 · Data updated 2026-11-12
This study is testing if a special treatment called remote ischemic conditioning can help patients with coronary artery disease recover better after heart surgery without using a heart-lung machine.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 648 (estimated) |
| Sponsor | First Affiliated Hospital Xi'an Jiaotong University Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Status | Recruiting |
| Started | November 22, 2023 |
| Main results expected | December 31, 2028 |
| Study ends | March 31, 2029 |
| Registry record updated | July 12, 2024 |
| Trial ID | NCT06141525 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 75 with diagnosed coronary artery disease requiring off-pump CABG and normal left ventricular function.
✕Probably not a fit
Patients with severe cardiac insufficiency, acute coronary syndromes, or other significant comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial investigates the effects of remote ischemic conditioning (RIC) on patients diagnosed with coronary artery disease who are scheduled for off-pump coronary artery bypass grafting (CABG). A total of 648 participants will be enrolled across five centers in China, with patients randomly assigned to either the RIC group or a control group. The primary outcome measured will be the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE) within three months post-surgery. The study aims to determine if RIC can enhance short-term prognosis by reducing ischemia-reperfusion injury.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery and reduce complications for patients undergoing off-pump CABG.
How similar studies have gone: Previous studies have shown promising results with remote ischemic conditioning in various settings, suggesting potential for success in this novel application.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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First Affiliated Hospital of Xi'an Jiantong University
Xi'an, Shaanxi, China Recruiting
Study contacts
- Principal investigator: Yang Yan — First Affiliated Hospital Xi'an Jiaotong University
- Study coordinator: Yang Yan
- Email: yangyan3@xjtu.edu.cn
- Phone: +86.29.85323869
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.