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CompletedNCT02812901TOMISUpdated Feb 5, 2026

Tolerance of Myocardium to Ischemia Injury

An interventional study of cardiac surgery scheduled in the morning and cardiac surgery scheduled in the afternoon in Reperfusion Injury and Myocardial Ischemia, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jan 2016, registered Jun 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

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Conditions studied

  • Reperfusion Injury
  • Myocardial Ischemia
03

In context

Reperfusion Injury

271 studies on the registry are indexed under Reperfusion Injury; 42 are open to participants now.

This study's enrollment of 88 is above the median of 61 across 215 interventional studies indexed under Reperfusion Injury.

Browse Reperfusion Injury studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
88 participants (actual)

Study arms

  • Other
    morning group

    cardiac surgery scheduled in the morning

    Procedure: cardiac surgery scheduled in the morning

  • Other
    afternoon group

    cardiac surgery scheduled in the afternoon

    Procedure: cardiac surgery scheduled in the afternoon

Interventions

  • Procedurecardiac surgery scheduled in the morning

    cardiac surgery scheduled in the morning

  • Procedurecardiac surgery scheduled in the afternoon

    cardiac surgery scheduled in the afternoon

06

What researchers measure

Primary outcomes

  1. ischemia reperfusion injury in ex vivo conditions

    measurement of hs troponin T released by the myocardium samples in the superfusion solution after ex vivo conditions mimicking ischemia-reperfusion

    Time frame: the day of the myocardial biopsy

07

Study locations

1 site
  • Lille University Hospital
    Lille, 59000, France
08

References and documents

Publications

  • 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. PubMed 29107324 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02812901
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Jun 24, 2016
Start date
Jan 2016
Primary completion
Jul 2017
Completion
Jul 2017
Last update
Feb 5, 2026

Study contacts

David Montaigne, MD, PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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