Tolerance of Myocardium to Ischemia Injury

NCT ID: NCT02812901

Last Updated: 2026-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-07-31

Brief Summary

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This study aims to understand the impact of time-of-the day on human myocardial tolerance to ischemia-reperfusion by exploring atrial myocardium biopsied during cardiac surgery. Patients scheduled for non-urgent cardiac surgery (coronary artery by-pas graft and/or aortic valve replacement) will be assigned to a morning or an afternoon cardiac surgery based on randomization. Myocardial biopsies will be explored in ex vivo conditions mimicking ischemia-reperfusion.

Detailed Description

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Conditions

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Reperfusion Injury Myocardial Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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morning group

cardiac surgery scheduled in the morning

Group Type OTHER

cardiac surgery scheduled in the morning

Intervention Type PROCEDURE

cardiac surgery scheduled in the morning

afternoon group

cardiac surgery scheduled in the afternoon

Group Type OTHER

cardiac surgery scheduled in the afternoon

Intervention Type PROCEDURE

cardiac surgery scheduled in the afternoon

Interventions

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cardiac surgery scheduled in the morning

cardiac surgery scheduled in the morning

Intervention Type PROCEDURE

cardiac surgery scheduled in the afternoon

cardiac surgery scheduled in the afternoon

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient scheduled for coronary artery bypass graft surgery and/or aortic valve replacement with extra-corporeal circulation
* Patient in sinus rhythm at the time of surgery
* Patient older than 18
* Patient able to understand the information and consent forms

Exclusion Criteria

* Medical history of type 2 diabetes, atrial fibrillation or use of class III anti-arhythmic drug
* left ventricle ejection fraction \< 40%
* Pregnancy
* Patient in emergency condition
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Montaigne, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lille University Hospital

Locations

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Lille University Hospital

Lille, , France

Site Status

Countries

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France

References

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Montaigne D, Marechal X, Modine T, Coisne A, Mouton S, Fayad G, Ninni S, Klein C, Ortmans S, Seunes C, Potelle C, Berthier A, Gheeraert C, Piveteau C, Deprez R, Eeckhoute J, Duez H, Lacroix D, Deprez B, Jegou B, Koussa M, Edme JL, Lefebvre P, Staels B. Daytime variation of perioperative myocardial injury in cardiac surgery and its prevention by Rev-Erbalpha antagonism: a single-centre propensity-matched cohort study and a randomised study. Lancet. 2018 Jan 6;391(10115):59-69. doi: 10.1016/S0140-6736(17)32132-3. Epub 2017 Oct 26.

Reference Type RESULT
PMID: 29107324 (View on PubMed)

Other Identifiers

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2015-A00864-45

Identifier Type: OTHER

Identifier Source: secondary_id

2014-56

Identifier Type: -

Identifier Source: org_study_id

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