Using remote ischemic conditioning to improve outcomes for patients undergoing off-pump coronary artery bypass grafting
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 648 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital Xi'an Jiaotong University Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT06141525 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with diagnosed coronary artery disease requiring off-pump CABG and normal left ventricular function.
Not a fit: Patients with severe cardiac insufficiency, acute coronary syndromes, or other significant comorbidities may not benefit from this study.
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 performed: Previous studies have shown promising results with remote ischemic conditioning in various settings, suggesting potential for success in this novel application.
Eligibility criteria
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 this trial is running
Xi'an, Shaanxi
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.