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

Infective Endocarditis Clinical Trial

— EIPSL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04992923
• Other study ID #: APHP200685
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis

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