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Tolerance of Myocardium to Ischemia Injury (TOMIS)

U

University Hospital, Lille

Status

Completed

Conditions

Myocardial Ischemia
Reperfusion Injury

Treatments

Procedure: cardiac surgery scheduled in the morning
Procedure: cardiac surgery scheduled in the afternoon

Study type

Interventional

Funder types

Other

Identifiers

NCT02812901
2015-A00864-45 (Other Identifier)
2014-56

Details and patient eligibility

About

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.

Enrollment

88 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

88 participants in 2 patient groups

morning group
Other group
Description:
cardiac surgery scheduled in the morning
Treatment:
Procedure: cardiac surgery scheduled in the morning
afternoon group
Other group
Description:
cardiac surgery scheduled in the afternoon
Treatment:
Procedure: cardiac surgery scheduled in the afternoon

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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