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

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.

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Key information

Conditions

Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ROUEN Hospital University

Rouen, 76000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cardiac surgery

Procedure

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

Primary outcomes

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

Time frame: 2 hours after the release of extracorporeal circulation

ELISA technique (comparison of protein levels) + quantitative RT-PCR (comparison of normalized mRNA expression concentrations relative to a control gene).

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: STRECH

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Oct 29, 2018
Registry last updated: Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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