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Tolerance of Myocardium to Ischemia Injury

Morning / Afternoon Variation in Myocardial Ischemia Tolerance

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02812901
Acronym
TOMIS
Enrollment
88
Registered
2016-06-24
Start date
2016-01-01
Completion date
2017-07-01
Last updated
2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Ischemia, Reperfusion Injury

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.

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

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
ischemia reperfusion injury in ex vivo conditionsthe day of the myocardial biopsymeasurement of hs troponin T released by the myocardium samples in the superfusion solution after ex vivo conditions mimicking ischemia-reperfusion

Countries

France

Contacts

PRINCIPAL_INVESTIGATORDavid Montaigne, MD, PhD

Lille University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026