NCT04992923

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
180mo left

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress28%
Sep 2020Mar 2041

Study Start

First participant enrolled

September 15, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2020

Completed
9 months until next milestone

First Posted

Study publicly available on registry

August 5, 2021

Completed
19.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2040

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2041

Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

20 years

First QC Date

November 5, 2020

Last Update Submit

November 18, 2025

Conditions

Keywords

Infective endocarditis, prospective,prognosis, biomarker, embolism

Outcome Measures

Primary Outcomes (1)

  • All-cause in hospital mortality

    All-cause mortality during the length of hospital stay

    up to 90 days

Secondary Outcomes (12)

  • All-cause mortality

    an average of 10 years

  • 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

    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

  • +7 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All the patients with IE admitted at Cardiology institute of the Pitié-Salpêtrière hospital

You may qualify if:

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

You may not qualify if:

  • Opposition of the patient to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APHP Pitié-Salpêtrière Hospital, Department of Cardiology

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

EndocarditisEmbolism

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesEmbolism and ThrombosisVascular Diseases

Study Officials

  • Nadjib Hammoudi, MD, PhD

    Pitié-Salpêtrière Hospital (AP-HP)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadjib Hammoudi, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2020

First Posted

August 5, 2021

Study Start

September 15, 2020

Primary Completion (Estimated)

September 1, 2040

Study Completion (Estimated)

March 1, 2041

Last Updated

November 21, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations