Clinical trial NCT04992923: Prospective Cohort Study of Patients With Infective Endocarditis at Pitié-Salpêtrière Hospital
Official title: Prospective Cohort Study of Patients With Infective Endocarditis Admitted at Cardiology Institute of Pitié-Salpêtrière Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infective Endocarditis
Keywords: Infective endocarditis, prospective,
prognosis, biomarker, embolism
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients with IE admitted at Cardiology institute of the Pitié-Salpêtrière hospital

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Opposition of the patient to participate

Primary outcomes:
measure: All-cause in hospital mortality
timeFrame: up to 90 days
Secondary outcomes:
measure: All-cause mortality
timeFrame: an average of 10 years
measure: symptomatic or asymptomatic systemic embolism
timeFrame: up to 90 days after inclusion
measure: 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
timeFrame: inclusion
measure: 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
timeFrame: up to 90 days after inclusion
measure: heart failure, intracranial hemorrhage, or false vascular aneurysm during hospitalization
timeFrame: up to 90 days after inclusion
measure: Stroke
timeFrame: 90 days after inclusion
measure: composite criteria of stroke, Intracranial hemorrhage, hospitalization due to cardiovascular cause or IE recurrence
timeFrame: 1 year after inclusion
measure: composite criteria of stroke, Intracranial hemorrhage, hospitalization due to cardiovascular cause or IE recurrence
timeFrame: through study completion, an average of 10 years
measure: composite criteria of all-cause mortality, stroke or intracranial hemorrhage, severe hemorrhage as defined by BARC score ≥ 3
timeFrame: 1 year after inclusion
measure: composite criteria of all-cause mortality, stroke or intracranial hemorrhage, severe hemorrhage as defined by BARC score ≥ 3
timeFrame: through study completion, an average of 10 years
measure: 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
timeFrame: 1 year after inclusion
measure: Occurrence of contrast-associated acute kidney injury during the length of hospital stay
timeFrame: up to 90 days after inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: APHP Pitié-Salpêtrière Hospital, Department of Cardiology
Study officials:
affiliation: Pitié-Salpêtrière Hospital (AP-HP)
name: Nadjib Hammoudi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: