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

Recruiting

• Conditions: Infective Endocarditis

• Registration Number: NCT04992923
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2020-09-15
• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2040-09
• Study Completion: 2041-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

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

Exclusion Criteria

• Opposition of the patient to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause in hospital mortality	up to 90 days	All-cause mortality during the length of hospital stay

Secondary Outcome Measures

Name	Time	Method
symptomatic or asymptomatic systemic embolism	up to 90 days after inclusion	symptomatic or asymptomatic systemic embolism confirmed by any type of imaging during initial hospitalization
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	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 within 90 days after admission
heart failure, intracranial hemorrhage, or false vascular aneurysm during hospitalization	up to 90 days after inclusion	Occurrence of heart failure, intracranial hemorrhage, or false vascular aneurysm during the length of hospital stay
All-cause mortality	an average of 10 years	mortality at longest follow-up
composite criteria of stroke, Intracranial hemorrhage, hospitalization due to cardiovascular cause or IE recurrence	through study completion, an average of 10 years	Occurrence of a composite criteria of stroke, Intracranial hemorrhage, hospitalization due to cardiovascular cause or IE recurrence at the longest follow-up
Occurrence of contrast-associated acute kidney injury during the length of hospital stay	up to 90 days after inclusion	rise of serum creatinine \> 26.5 mcmol/L or \> 50% elevation from baseline over the course of hospitalization
Stroke	90 days after inclusion	Stroke during the length of hospital stay
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	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 at one year
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	Occurrence of a composite criteria of all-cause mortality, stroke or intracranial hemorrhage, severe hemorrhage as defined by BARC score ≥ 3 at the longest follow-up

Trial Locations

Locations (1)

APHP Pitié-Salpêtrière Hospital, Department of Cardiology; 🇫🇷 Paris, France