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Study of the Expression of Endoplasmic Reticulum Stress During Extracorporeal Circulation in Humans

Study of the Expression of Endoplasmic Reticulum Stress During Extracorporeal Circulation in Humans

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03722979
Acronym
STRECH
Enrollment
53
Registered
2018-10-29
Start date
2018-07-07
Completion date
2019-03-06
Last updated
2026-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

Brief 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.

Interventions

PROCEDURECardiac surgery

The study will enroll patients having a planned cardiac surgery under extracorporeal circulation (CEC)

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 circulation2 hours after the release of extracorporeal circulationELISA technique (comparison of protein levels) + quantitative RT-PCR (comparison of normalized mRNA expression concentrations relative to a control gene).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 18, 2026