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Tolerance of Myocardium to Ischemia Injury (TOMIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02812901
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Reperfusion Injury Myocardial Ischemia Procedure: cardiac surgery scheduled in the morning Procedure: cardiac surgery scheduled in the afternoon Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Morning / Afternoon Variation in Myocardial Ischemia Tolerance
Actual Study Start Date : January 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
morning group
cardiac surgery scheduled in the morning
Procedure: cardiac surgery scheduled in the morning
cardiac surgery scheduled in the morning

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




Primary Outcome Measures :
  1. ischemia reperfusion injury in ex vivo conditions [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812901


Locations
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France
Lille University Hospital
Lille, France, 59000
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: David Montaigne, MD, PhD Lille University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02812901    
Other Study ID Numbers: 2014-56
2015-A00864-45 ( Other Identifier: ID-RCB number, ANSM )
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Ischemia
Coronary Artery Disease
Reperfusion Injury
Ischemia
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Postoperative Complications