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

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.

Study Overview

• Status: Unknown
• Conditions: Cardiac Surgery
• Intervention / Treatment: Procedure: Cardiac surgery

• Study Type: Interventional
• Enrollment (Anticipated): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76000
    • Recruiting
    • ROUEN Hospital University
    • Contact: Cécile POURCHER; Phone Number: 02 32 88 82 65; Email: Cecile.Pourcher@chu-rouen.fr
    • Contact: Julien BLOT; Phone Number: 02 32 88 82 65; Email: julien.blot@chu-rouen.fr
    • Principal Investigator: Thomas Clavier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: All patients	Procedure: Cardiac surgery; The study will enroll patients having a planned cardiac surgery under extracorporeal circulation (CEC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	ELISA technique (comparison of protein levels) + quantitative RT-PCR (comparison of normalized mRNA expression concentrations relative to a control gene).	2 hours after the release of extracorporeal circulation

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2018
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (Actual): October 29, 2018

Study Record Updates

• Last Update Posted (Actual): October 29, 2018
• Last Update Submitted That Met QC Criteria: October 25, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2017/179/HP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No