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Post-Operative Myocardial Incident & Atrial Fibrillation (POMI-AF)

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ClinicalTrials.gov Identifier: NCT03376165
Recruitment Status : Not yet recruiting
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
To explore predictors of major cardio-vascular events after cardiac surgery and trans-catheter valve implantation with a specific interest in studying mechanisms linking pre-operative leukocyte, fat and myocardial phenotypes with post-intervention outcomes.

Condition or disease
Valve Heart Disease Coronary Artery Disease

Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Study of Patients Undergoing Cardiac Surgery or Implantation of a Percutaneous Valve Prosthesis
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2028
Estimated Study Completion Date : January 2028

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. major cardio-vascular events after cardiac intervention (surgery or transcatheter valve implantation) [ Time Frame: from the day of intervention to 10 years ]
    cardiovascular death, hospitalisation for heart failure, stroke, myocardial infarction, re-intervention


Secondary Outcome Measures :
  1. peri-operative myocardial injury [ Time Frame: 3 days following intervention ]
    Area Under the Curve of blood troponin release during the 3 days following cardiac intervention

  2. post-operative myocardial infarction (type 5 myocardial infarction) [ Time Frame: 10 days following intervention ]
    myocardial infarction during the peri-operative time

  3. post-operative atrial fibrillation [ Time Frame: 10 days following intervention ]
    atrial fibrillation onset during post-op hospitalisation

  4. major cardio-vascular events after cardiac intervention (surgery or transcatheter valve implantation) [ Time Frame: from the day of intervention to 1 year ]
    cardiovascular death, hospitalisation for heart failure, stroke, myocardial infarction, re-intervention


Biospecimen Retention:   Samples With DNA

for all patients, blood samples with isolation of peripheral blood mononuclear cells, subcutaneous fat

for patients undergoing cardiac surgery right atrial and left ventricle myocardial samples; Epicardial and mediastinal fat



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adult patients schedulled for cardiac surgery (coronary artery bypass graft surgery and/or valvular surgery) or transcatheter valve implantation and referred to the University Hospital of Lille with inclusion criteria and no exclusion criteria.
Criteria

Inclusion Criteria:

  • patients scheduled for cardiac surgery (coronary artery bypass graft surgery and/or valvular surgery) or transcatheter valve implantation

Exclusion Criteria:

  • pregnant woman
  • urgent surgery or intervention
  • not able to consent to the protocol

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): NCT03376165


Contacts
Contact: David Montaigne, Prof. 320445230 ext +33 david.montaigne@chru-lille.fr

Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: David Montaigne, Prof. University Hospital, Lille

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03376165     History of Changes
Other Study ID Numbers: CB2015_75
2017-A00852-51 ( Other Identifier: ID-RCB number, ANSM )
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
prognosis
translational research

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases