NCT03376165

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jan 2018Jan 2028

First Submitted

Initial submission to the registry

December 11, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 30, 2018

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

9.9 years

First QC Date

December 11, 2017

Last Update Submit

February 3, 2023

Conditions

Valve Heart DiseaseCoronary Artery Disease

Keywords

prognosistranslational research

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • peri-operative myocardial injury

    3 days following intervention

  • post-operative myocardial infarction (type 5 myocardial infarction)

    10 days following intervention

  • post-operative atrial fibrillation

    10 days following intervention

  • major cardio-vascular events after cardiac intervention (surgery or transcatheter valve implantation)

    from the day of intervention to 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Cardiologie, CHU

Lille, France

RECRUITING

Related Publications (2)

  • 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. Epub 2024 Aug 29.

    PMID: 39206728DERIVED

  • 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 Postoperative Atrial Fibrillation. J Am Coll Cardiol. 2023 Apr 4;81(13):1263-1278. doi: 10.1016/j.jacc.2023.01.036.

    PMID: 36990546DERIVED

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

MeSH Terms

Conditions

Heart Valve DiseasesCoronary Artery Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • David Montaigne, Prof.

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Montaigne, Prof.

CONTACT

320445230david.montaigne@chru-lille.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2017

First Posted

December 18, 2017

Study Start

January 30, 2018

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

February 6, 2023

Record last verified: 2023-02

Locations

FR(1)