Protection During Cardiac Surgery. (NCT03230136) | Clinical Trial Compass
CompletedNot Applicable
Protection During Cardiac Surgery.
France210 participantsStarted 2018-01-03
Plain-language summary
This trial investigates whether a multimodal cardioprotection per-surgery therapeutic strategy could reduce myocardial injury in patients undergoing cardiac surgery compared to traditional management. The primary endpoint is the AUC (area under the curve) of the hypersensitive troponin I. Blood samples will be collected during the 72 hours following the aortic cross-unclamping. This trial is a French, multicenter, randomized, single-blinded and controlled trial. 210 patients will be enrolled with a clinical follow-up during 30 days.
Who can participate
Age range
18 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 old
* Aortic valve surgery (aortic valve replacement associated or not with coronary artery bypass graft, Bentall surgery or Tirone David surgery)
* Signed informed consent
Exclusion Criteria:
* Emergency surgery
* Redo surgery
* Patient treated with Nicorandil, repaglinid or sulfonylurea 48 hours prior to surgery
* Low cardiac output requiring catecholamine infusion or circulatory assistance prior to surgery
* Severe renal failure: dialysis or glomerular filtration rate \< 30 mL/min
* Severe liver failure (spontaneous INR \>2)
* Severe respiratory insufficiency (VEMS \<40% of predicted value)
* Contra-indication to sevoflurane and propofol
* Myocardial infarction \< 7 days
* Severe upper limb arterial disease
* Heparin-induced thrombopenia
* Active infection under antibiotic treatment
* Any other surgery combined with the aortic valve surgery: myotomia of Morrow (hypertrophic myocardiopathy), treatment of heart rhythm disorder, inter-atrial communication closure, mitral valve replacement, tricuspid valve replacement, pulmonary valve replacement.
* Pregnant women
* Currently participating in another trial which may interfere with ProCCard results
* Not benefiting from a social insurance or similar system
* Patient under legal protection
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
1
Area under the plasma concentration versus time curve (AUC) of Hypersensitive Troponin I