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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04992923
Other study ID # APHP200685
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 15, 2020
Est. completion date March 2041

Study information

Verified date November 2023
Source Assistance Publique - Hôpitaux de Paris
Contact Nadjib Hammoudi, MD, PhD
Phone +33 142165535
Email nadjib.hammoudi@aphp.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 700
Est. completion date March 2041
Est. primary completion date September 2040
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with confirmed IE according to European Society of Cardiology criteria Exclusion Criteria: - Opposition of the patient to participate

Study Design


Locations

Country Name City State
France APHP Pitié-Salpêtrière Hospital, Department of Cardiology Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause in hospital mortality All-cause mortality during the length of hospital stay up to 90 days
Secondary All-cause mortality mortality at longest follow-up an average of 10 years
Secondary symptomatic or asymptomatic systemic embolism symptomatic or asymptomatic systemic embolism confirmed by any type of imaging during initial hospitalization up to 90 days after inclusion
Secondary 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 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 at the admission Initial Hospitalization inclusion
Secondary 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 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 up to 90 days after inclusion
Secondary heart failure, intracranial hemorrhage, or false vascular aneurysm during hospitalization Occurrence of heart failure, intracranial hemorrhage, or false vascular aneurysm during the length of hospital stay up to 90 days after inclusion
Secondary Stroke Stroke during the length of hospital stay 90 days after inclusion
Secondary composite criteria of stroke, Intracranial hemorrhage, hospitalization due to cardiovascular cause or IE recurrence Occurrence of a composite criteria of stroke, Intracranial hemorrhage, hospitalization due to cardiovascular cause or IE recurrence at one year 1 year after inclusion
Secondary composite criteria of stroke, Intracranial hemorrhage, hospitalization due to cardiovascular cause or IE recurrence Occurrence of a composite criteria of stroke, Intracranial hemorrhage, hospitalization due to cardiovascular cause or IE recurrence at the longest follow-up through study completion, an average of 10 years
Secondary composite criteria of all-cause mortality, stroke or intracranial hemorrhage, severe hemorrhage as defined by BARC score = 3 on-year composite criteria of all-cause mortality, stroke or intracranial hemorrhage, severe hemorrhage as defined by BARC score = 3 1 year after inclusion
Secondary composite criteria of all-cause mortality, stroke or intracranial hemorrhage, severe hemorrhage as defined by BARC score = 3 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 through study completion, an average of 10 years
Secondary 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 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 1 year after inclusion
Secondary Occurrence of contrast-associated acute kidney injury during the length of hospital stay rise of serum creatinine > 26.5 mcmol/L or > 50% elevation from baseline over the course of hospitalization up to 90 days after inclusion
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