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Tolerance of Myocardium to Ischemia Injury (TOMIS)

Primary Purpose

Reperfusion Injury, Myocardial Ischemia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cardiac surgery scheduled in the morning
cardiac surgery scheduled in the afternoon
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Reperfusion Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Lille University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

morning group

afternoon group

Arm Description

cardiac surgery scheduled in the morning

cardiac surgery scheduled in the afternoon

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 22, 2016
Last Updated
August 29, 2017
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT02812901
Brief Title
Tolerance of Myocardium to Ischemia Injury
Acronym
TOMIS
Official Title
Morning / Afternoon Variation in Myocardial Ischemia Tolerance
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reperfusion Injury, Myocardial Ischemia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
morning group
Arm Type
Other
Arm Description
cardiac surgery scheduled in the morning
Arm Title
afternoon group
Arm Type
Other
Arm Description
cardiac surgery scheduled in the afternoon
Intervention Type
Procedure
Intervention Name(s)
cardiac surgery scheduled in the morning
Intervention Description
cardiac surgery scheduled in the morning
Intervention Type
Procedure
Intervention Name(s)
cardiac surgery scheduled in the afternoon
Intervention Description
cardiac surgery scheduled in the afternoon
Primary Outcome Measure Information:
Title
ischemia reperfusion injury in ex vivo conditions
Description
measurement of hs troponin T released by the myocardium samples in the superfusion solution after ex vivo conditions mimicking ischemia-reperfusion
Time Frame
the day of the myocardial biopsy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Montaigne, MD, PhD
Organizational Affiliation
Lille University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lille University Hospital
City
Lille
ZIP/Postal Code
59000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29107324
Citation
Montaigne D, Marechal X, Modine T, Coisne A, Mouton S, Fayad G, Ninni S, Klein C, Ortmans S, Seunes C, Potelle C, Berthier A, Gheeraert C, Piveteau C, Deprez R, Eeckhoute J, Duez H, Lacroix D, Deprez B, Jegou B, Koussa M, Edme JL, Lefebvre P, Staels B. Daytime variation of perioperative myocardial injury in cardiac surgery and its prevention by Rev-Erbalpha antagonism: a single-centre propensity-matched cohort study and a randomised study. Lancet. 2018 Jan 6;391(10115):59-69. doi: 10.1016/S0140-6736(17)32132-3. Epub 2017 Oct 26.
Results Reference
derived

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Tolerance of Myocardium to Ischemia Injury

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