Tolerance of Myocardium to Ischemia Injury
TOMIS
Morning / Afternoon Variation in Myocardial Ischemia Tolerance
2 other identifiers
interventional
88
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 22, 2016
CompletedFirst Posted
Study publicly available on registry
June 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedFebruary 5, 2026
August 1, 2017
1.5 years
June 22, 2016
February 2, 2026
Conditions
Outcome Measures
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
the day of the myocardial biopsy
Study Arms (2)
morning group
OTHERcardiac surgery scheduled in the morning
afternoon group
OTHERcardiac surgery scheduled in the afternoon
Interventions
cardiac surgery scheduled in the morning
cardiac surgery scheduled in the afternoon
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lille University Hospital
Lille, 59000, France
Related Publications (1)
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.
PMID: 29107324RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Montaigne, MD, PhD
University Hospital, Lille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2016
First Posted
June 24, 2016
Study Start
January 1, 2016
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
February 5, 2026
Record last verified: 2017-08