Not Yet RecruitingNot Applicable

Protective Effect of EECP Against Negative Inflammatory Response and Organ Dysfunction After Cardiovascular Surgery

China400 participantsStarted 2025-12-31

Plain-language summary

Enhanced external counterpulsation (EECP) is a noninvasive, non-pharmacologic intervention proven to increase nitric oxide bioavailability in patients with coronary artery disease. Although EECP showed short-term effects in improving coronary flow in patients with coronary slow flow, whether such improvement is durable remains uncertain, and the relationships between such improvement and changes in multiple organ functions as well as inflammatory markers have not been elucidated. The purpose of this study will be to evaluate the potential clinical benefits of EECP on organ function and proinflammatory cytokine concentrations during post-acute sequela of cardiovascular surgery.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \> 18 years; * Patients with Stable angina pectoris, unstable angina pectoris, acute myocardial infarction, congestive heart failure, cardiogenic shock; * Patients chronic heart failure; * Patients are ready to received cardiovascular surgery during this hospital admission. * Patients agree to participate in the study and sign an informed consent form. Exclusion Criteria: 1\. Moderate to severe aortic insufficiency; 2. Dissection aneurysm; 3. Significant pulmonary hypertension; 4, A variety of bleeding diseases or bleeding tendencies, or use anticoagulants, INR\>2.0; 5, active phlebitis, venous thrombosis; 6. There is an infection in the counterpulsating limb; 7. Uncontrolled hyperhypertension (\>170/110mmHg); 8. Uncontrolled arrhythmias: frequent premature beats, rapid atrial fibrillation, etc. 9\. Pregnancy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is testing a treatment called EECP after cardiovascular surgery — can you explain what EECP actually involves and whether it would be appropriate given my specific condition, whether that's coronary heart disease, heart failure, or another diagnosis?
2The trial is measuring something called a SOFA score as its main outcome — can you explain what that score measures and why tracking organ dysfunction after cardiopulmonary bypass surgery is important for someone in my situation?
3Since this trial hasn't started recruiting yet, how long do you think it might be before it's actually enrolling patients, and would waiting potentially affect my treatment timeline or outcomes?
4Given that this study is listed as Phase NA, meaning it may be exploratory or device-based rather than a traditional drug trial, what do we already know about EECP's safety profile after cardiovascular surgery, and what unknowns would I be taking on by participating?
5If this trial isn't open yet or turns out not to be a good fit for me, what standard-of-care options exist to help protect my organs and manage inflammation after cardiovascular surgery in the meantime?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

SOFA score

Timeframe: within the prior 7 days after cardiac surgery.

Trial details

NCT IDNCT06728605

SponsorNanjing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

Contact for this trial

Hong Liu, MD

18801281613 dr.hongliu@foxmail.com

View on ClinicalTrials.gov More Coronary Heart Disease (CHD) trials