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

University Hospital, Lille1 site in 1 country1,500 target enrollmentJanuary 30, 2018

ConditionsValve Heart Disease Coronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Valve Heart Disease
Sponsor: University Hospital, Lille
Enrollment: 1500
Locations: 1
Primary Endpoint: major cardio-vascular events after cardiac intervention (surgery or transcatheter valve implantation)
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 30, 2018

End Date

January 2028

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University Hospital, Lille

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

post-operative myocardial infarction (type 5 myocardial infarction)(10 days following intervention)
major cardio-vascular events after cardiac intervention (surgery or transcatheter valve implantation)(from the day of intervention to 1 year)
peri-operative myocardial injury(3 days following intervention)
post-operative atrial fibrillation(10 days following intervention)