Menu
Recruiting NCT03376165

Post-Operative Myocardial Incident & Atrial Fibrillation

Observational Valve Heart Disease Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Valve Heart Disease, Coronary Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • major cardio-vascular events after cardiac intervention (surgery or transcatheter valve implantation) [Time frame: from the day of intervention to 10 years]
Secondary outcome measures (4)
  • peri-operative myocardial injury [Time frame: 3 days following intervention]
  • post-operative myocardial infarction (type 5 myocardial infarction) [Time frame: 10 days following intervention]
  • post-operative atrial fibrillation [Time frame: 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]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hôpital Cardiologie, CHU — Lille

Publications

  • Ninni S, Dombrowicz D, Kuznetsova T, Vicario R, Gao V, Molendi-Coste O, Haas J, Woitrain E, Coisne A, Neele AE, Prange K, Willemsen L, Aghezzaf S, Fragkogianni S, Tazibet A, Pineau L, White JR, Eeckhoute J, Koussa M, Dubrulle H, Juthier F, Soquet J, Vincentelli A, Edme JL, de Winther M, Geissmann F, Staels B, Montaigne D. Hematopoietic Somatic Mosaicism Is Associated With an Increased Risk of Post PMID 36990546
  • Ninni S, Vicario R, Coisne A, Woitrain E, Tazibet A, Stewart CM, Diaz LA Jr, White JR, Koussa M, Dubrulle H, Juthier F, Jungling M, Vincentelli A, Edme JL, Nattel S, de Winther M, Geissmann F, Dombrowicz D, Staels B, Montaigne D. Clonal Hematopoiesis Is Associated With Long-Term Adverse Outcomes Following Cardiac Surgery. J Am Heart Assoc. 2024 Sep 3;13(17):e034255. doi: 10.1161/JAHA.123.034255. E PMID 39206728

Identifiers

NCT: NCT03376165 · CB2015_75 · 2017-A00852-51

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗