Tolerance of Myocardium to Ischemia Injury

Myocardial Ischemia Clinical Trial

— TOMIS  

Official title:

Morning / Afternoon Variation in Myocardial Ischemia Tolerance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02812901
• Other study ID #: 2014-56
• Secondary ID: 2015-A00864-45
• Status: Completed
• Phase: N/A
• First received: June 22, 2016
• Last updated: August 29, 2017
• Start date: January 2016
• Est. completion date: July 2017

Study information

• Verified date: August 2017
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia
• Reperfusion Injury

Intervention

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

Locations

Country	Name	City	State
France	Lille University Hospital	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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