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

May 11, 2026 updated by: University Hospital, Lille

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lille, France
        • Recruiting
        • Hôpital Cardiologie, CHU
        • Principal Investigator:
          • David Montaigne, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from the day of intervention to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 days following intervention
post-operative myocardial infarction (type 5 myocardial infarction)
Time Frame: 10 days following intervention
myocardial infarction during the peri-operative time
10 days following intervention
post-operative atrial fibrillation
Time Frame: 10 days following intervention
atrial fibrillation onset during post-op hospitalisation
10 days following intervention
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
from the day of intervention to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: David Montaigne, Prof., University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2018

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

December 11, 2017

First Submitted That Met QC Criteria

December 15, 2017

First Posted (Actual)

December 18, 2017

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CB2015_75
  • 2017-A00852-51 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe