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Clinical Trials/NCT04992923
NCT04992923
Recruiting
Not Applicable

Prospective Cohort Study of Patients With Infective Endocarditis Admitted at Cardiology Institute of Pitié-Salpêtrière Hospital

Assistance Publique - Hôpitaux de Paris1 site in 1 country700 target enrollmentSeptember 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infective Endocarditis
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
700
Locations
1
Primary Endpoint
All-cause in hospital mortality
Status
Recruiting
Last Updated
5 months ago

Overview

Brief Summary

Infective endocarditis (IE) is a severe condition associated with high mortality. Due to the relative low prevalence of IE, prospective data are lacking and current guidelines are mostly based on expert consensus with low level of evidence. IE is also associated with severe complications especially strokes that occur in about one third of the patients.

In order to improve the management and the prognosis of IE, clinical data from larges prospective cohort studies are needed.

Detailed Description

The study will take place at the Cardiology institute of the Pitié-Salpêtrière hospital. All patients referred to this tertiary care center for IE management will be included. The characteristics of the patients (demographics, clinical, laboratory, and imaging data) at the time of IE diagnosis and during the follow-up will be collected. The patients will be followed up to 10 years after inclusion.

Registry
clinicaltrials.gov
Start Date
September 15, 2020
End Date
March 1, 2041
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with confirmed IE according to European Society of Cardiology criteria

Exclusion Criteria

  • Opposition of the patient to participate

Outcomes

Primary Outcomes

All-cause in hospital mortality

Time Frame: up to 90 days

All-cause mortality during the length of hospital stay

Secondary Outcomes

  • symptomatic or asymptomatic systemic embolism(up to 90 days after inclusion)
  • Association between coagulation biomarkers (D-dimer, fibrin monomer, circulating anticoagulant, von Willebrandt factor (VWF) antigen level, von Willebrandt factor (VWF) activity) assessed at the inclusion and the presence of systemic embolism(up to 90 days after inclusion)
  • heart failure, intracranial hemorrhage, or false vascular aneurysm during hospitalization(up to 90 days after inclusion)
  • All-cause mortality(an average of 10 years)
  • composite criteria of stroke, Intracranial hemorrhage, hospitalization due to cardiovascular cause or IE recurrence(through study completion, an average of 10 years)
  • Occurrence of contrast-associated acute kidney injury during the length of hospital stay(up to 90 days after inclusion)
  • Stroke(90 days after inclusion)
  • Association between occurrence of systemic embolism and the composite criteria of all-cause mortality, stroke or intracranial hemorrhage, severe hemorrhage as defined by BARC score ≥ 3(1 year after inclusion)
  • composite criteria of all-cause mortality, stroke or intracranial hemorrhage, severe hemorrhage as defined by BARC score ≥ 3(through study completion, an average of 10 years)

Study Sites (1)

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