Evaluate the Protective Effect of Conditioning With Sevoflurane on the Myocardium (NCT02851433) | Clinical Trial Compass
CompletedPhase 4
Evaluate the Protective Effect of Conditioning With Sevoflurane on the Myocardium
France82 participantsStarted 2015-10-14
Plain-language summary
Heart surgery is a considerable source of stress for the myocardium that must be minimized.
Troponin Ic is a reliable marker to determine the level of this myocardial stress.
Studies have shown that post-conditioning with AVH has a protective effect on the myocardium, if the treatment is initiated at the start of the ischemia.
The aim of this study is to evaluate the protective effect on the myocardium (by measuring troponin levels) of the association of pre-conditioning and post-conditioning with Sevoflurane (AVH) sedation administered during and after scheduled surgery for valve replacement, via sternotomy or thoracotomy compared with total intravenous anaesthesia with Propofol.
Who can participate
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:
* Patients who have provided informed written consent.
* Aortic valve replacement via sternotomy or thoracotomy, under Cardiopulmonary bypass (CPB).
* Anterograde cardioplegia with cold blood
Exclusion Criteria:
* Adults under guardianship.
* Patients without national health insurance cover.
* Epileptics.
* Heart grafted patients.
* Patients under 18 years and pregnant or beast-feeding women.
* Aortic dissections and vascular surgery.
* Contra-indications to treatment with Sevoflurane: hypersensitivity to halogen-based anaesthetic agents, myopathy, personal or family history of malignant hyperthermia, hyper-eosinophilia, liver disease, icterus or unexplained fever after anaesthesia with a halogen-based anaesthetic agent
* Contra-indications to treatment with Propofol: known hypersensitivity to propofol or one of the constituents of the specific form used, hypersensitivity to peanuts or soja.
* pre-operative LVEF\<35%.
* Coronary artery bypass graft alone or associated.
* Mitral valve replacements.
* Warm cardioplegia.
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
Levels of troponin
Timeframe: Change at Hour 6, Hour 12, Hour 24, Hour 48 compared with baseline level