Tolerance of Myocardium to Ischemia Injury (TOMIS)

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)

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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