Cardiac SurgerySTRECHNCT03722979
Study of the Expression of Endoplasmic Reticulum Stress During Extracorporeal Circulation in Humans
A study testing Cardiac surgery in people with Cardiac Surgery, run by University Hospital, Rouen at 1 site in France.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Cardiac surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2018to 6 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cardiac Surgery
- Being tested
- Cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgeryProcedure or surgery
The study will enroll patients having a planned cardiac surgery under extracorporeal circulation (CEC)
| Study group | Role | What they receive |
|---|---|---|
| All patients | Other | Not described Receives: Procedure: Cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 hours after the release of extracorporeal circulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start7 Jul 2018
- Primary completion6 Mar 2019
- Study completion6 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722979
- Sponsor's protocol ID
- 2017/179/HP
- Acronym
- STRECH
- Status last verified
- Apr 2026
- First submitted
- 25 Oct 2018
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Clavier T, Demailly Z, Semaille X, Thill C, Selim J, Veber B, Doguet F, Richard V, Besnier E, Tamion F. A Weak Response to Endoplasmic Reticulum Stress Is Associated With Postoperative Organ Failure in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass. Front Med (Lausanne). 2021 Feb 15;7:613518. doi: 10.3389/fmed.2020.613518. eCollection 2020.
PubMed 33659258
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Expression of Endoplasmic Reticulum Stress During Extracorporeal Circulation in Humans
- ClinicalTrials.gov ID
- NCT03722979
- Acronym / sponsor ID
- STRECH / 2017/179/HP
- Conditions
- Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 7 Jul 2018 (actual)
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 6 Mar 2019 (actual)
- First posted
- 29 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Other | Procedure: Cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (10 listed)
- 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 ...
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac surgeryThe study will enroll patients having a planned cardiac surgery under extracorporeal circulation (CEC) | Procedure or surgery | All patients |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Results publication: PubMed 33659258Clavier T, Demailly Z, Semaille X, Thill C, Selim J, Veber B, Doguet F, Richard V, Besnier E, Tamion F. A Weak Response to Endoplasmic Reticulum Stress Is Associated With Postoperative Organ Failure in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass. Front Med (Lausanne). 2021 Feb 15;7:613518. doi: 10.3389/fmed.2020.613518. eCollection 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac surgery in people with Cardiac Surgery, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03722979, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.