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

Sponsor

University Hospital, Rouen (Other)

Overall Status

Unknown status

CT.gov ID

NCT03722979

Collaborator

(none)

Enrollment

Location

Arm

18.7

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Surgery	Procedure: Cardiac surgery	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

53 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Aug 9, 2018

Anticipated Primary Completion Date :

Mar 1, 2020

Anticipated Study Completion Date :

Mar 1, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Other: All patients

Procedure: Cardiac surgery

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

Outcome Measures

Primary Outcome Measures

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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ROUEN Hospital University	Rouen		France	76000

Sponsors and Collaborators

University Hospital, Rouen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Rouen

ClinicalTrials.gov Identifier:

NCT03722979

Other Study ID Numbers:

2017/179/HP

First Posted:

Oct 29, 2018

Last Update Posted:

Oct 29, 2018

Last Verified:

Oct 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 29, 2018