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NCT Number: NCT03376165

Post-Operative Myocardial Incident & Atrial Fibrillation

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.

Recruiting

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Key information

Conditions

Valve Heart Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Heart Valve Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Cardiologie, CHU

Lille, France

Location status: Recruiting

Location contact

David Montaigne, MD,PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

David Montaigne, Prof.

CONTACT

[email protected]

320445230 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: POMI-AF

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Dec 18, 2017
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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