Study of the Expression of Endoplasmic Reticulum Stress During Extracorporeal Circulation in Humans (NCT03722979) | Clinical Trial Compass
CompletedNot Applicable
Study of the Expression of Endoplasmic Reticulum Stress During Extracorporeal Circulation in Humans
France53 participantsStarted 2018-07-07
Plain-language summary
The links between systemic inflammation, endothelial dysfunction and endoplasmic reticulum (ER) stress in pre-clinical models make it an interesting potential therapeutic target, but there are no data describing SRE during severe inflammation in humans .
For an approach to the study of SRE in humans in a situation of systemic inflammation, the analysis of patients benefiting from an extra-corporeal circulation for a programmed cardiac surgery would allow a study under well described conditions of inflammation, standardized, with the possibility for each patient to be his own witness. Compared to a situation of secondary inflammation (sepsis, acute pancreatitis, trauma ...) the analysis of the patients under CEC allows more precise description of the kinetics of the activation of the SRE because the beginning of the inflammatory mechanism is known with precision.
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:
* Major patient (age ≥ 18 years)
* Patient undergoing cardiac surgery under extracorporeal circulation (duration of planned CEC \> 1h)
* Informed person, having read and signed his consent preoperatively no later than the day before the procedure.
* Person affiliated with a social security scheme
* Effective contraception in women of childbearing potential. For menopausal women, the diagnosis of menopause will be based on the gynecological history of the patient (age\> 50 years + amenorrhea for more than 12 months).
Exclusion Criteria:
* Patient with urgent cardiac surgery
* Patient with cardiac surgery without extracorporeal circulation
* Patient with surgery under "mini-CEC"
* Patient with simple aortic valve replacement or single / double coronary artery bypass (CEC duration typically \<1h)
* Patient with chronic autoimmune inflammatory disease, eg lupus, rheumatoid arthritis, inflammatory bowel disease ...
* Patient with progressive neoplastic disease
* Patient with underlying heart disease with left ventricular ejection fraction \<30%
* Pregnant or lactating woman
* Person deprived of liberty by an administrative or judicial decision or protected major subject (under tutorship or curatorship)
* Patient participating in another interventional clinical trial
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
Study of the variation of a marker of endoplasmic reticulum stress, between the pre- extracorporeal circulation (CEC) sample and the sample taken 2 hours after the release of extracorporeal circulation
Timeframe: 2 hours after the release of extracorporeal circulation