Tolerance of Myocardium to Ischemia Injury

Not Applicable

Completed

• Conditions: Reperfusion Injury; Myocardial Ischemia
• Interventions: Procedure: cardiac surgery scheduled in the morning; Procedure: cardiac surgery scheduled in the afternoon

• Registration Number: NCT02812901
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-24
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-29
• Last Update Posted: 2017-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
morning group	cardiac surgery scheduled in the morning	cardiac surgery scheduled in the morning
afternoon group	cardiac surgery scheduled in the afternoon	cardiac surgery scheduled in the afternoon

Primary Outcome Measures

Name	Time	Method
ischemia reperfusion injury in ex vivo conditions	the day of the myocardial biopsy	measurement of hs troponin T released by the myocardium samples in the superfusion solution after ex vivo conditions mimicking ischemia-reperfusion

Trial Locations

Locations (1)

Lille University Hospital; 🇫🇷 Lille, France