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NCT03376165 Clinical Trial

Post-Operative Myocardial Incident & Atrial Fibrillation

Coronary Artery Disease Clinical Trial

— POMI-AF  

Official title:
Longitudinal Study of Patients Undergoing Cardiac Surgery or Implantation of a Percutaneous Valve Prosthesis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03376165
Other study ID # CB2015_75
Secondary ID 2017-A00852-51
Status Recruiting
Phase
First received
Last updated
Start date January 30, 2018
Est. completion date January 2028

Study information
Verified date February 2023
Source University Hospital, Lille
Contact David Montaigne, Prof.
Phone 320445230
Email david.montaigne@chru-lille.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1500
Est. completion date January 2028
Est. primary completion date January 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Hôpital Cardiologie, CHU 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 major cardio-vascular events after cardiac intervention (surgery or transcatheter valve implantation) cardiovascular death, hospitalisation for heart failure, stroke, myocardial infarction, re-intervention from the day of intervention to 10 years
Secondary peri-operative myocardial injury Area Under the Curve of blood troponin release during the 3 days following cardiac intervention 3 days following intervention
Secondary post-operative myocardial infarction (type 5 myocardial infarction) myocardial infarction during the peri-operative time 10 days following intervention
Secondary post-operative atrial fibrillation atrial fibrillation onset during post-op hospitalisation 10 days following intervention
Secondary major cardio-vascular events after cardiac intervention (surgery or transcatheter valve implantation) cardiovascular death, hospitalisation for heart failure, stroke, myocardial infarction, re-intervention from the day of intervention to 1 year
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