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NCT Number: NCT04992923

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

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.

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Key information

Conditions

Infective Endocarditis Cardiovascular Diseases Embolism Embolism and Thrombosis Endocarditis Heart Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

APHP Pitié-Salpêtrière Hospital, Department of Cardiology

Paris, 75013, France

Location status: Recruiting

Location contact

Nadjib Hammoudi, MD, PhD

CONTACT

[email protected]

+33 142165535

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Opposition of the patient to participate

Treatment and study plan

Primary outcomes

  1. All-cause in hospital mortality

    Time frame: up to 90 days

    All-cause mortality during the length of hospital stay

Secondary outcomes

  1. All-cause mortality

    Time frame: an average of 10 years

    mortality at longest follow-up

  2. symptomatic or asymptomatic systemic embolism

    Time frame: up to 90 days after inclusion

    symptomatic or asymptomatic systemic embolism confirmed by any type of imaging during initial hospitalization

  3. 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

    Time frame: 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 at the admission Initial Hospitalization

  4. 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

    Time frame: 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

  5. heart failure, intracranial hemorrhage, or false vascular aneurysm during hospitalization

    Time frame: up to 90 days after inclusion

    Occurrence of heart failure, intracranial hemorrhage, or false vascular aneurysm during the length of hospital stay

  6. Stroke

    Time frame: 90 days after inclusion

    Stroke during the length of hospital stay

  7. composite criteria of stroke, Intracranial hemorrhage, hospitalization due to cardiovascular cause or IE recurrence

    Time frame: 1 year after inclusion

    Occurrence of a composite criteria of stroke, Intracranial hemorrhage, hospitalization due to cardiovascular cause or IE recurrence at one year

  8. composite criteria of stroke, Intracranial hemorrhage, hospitalization due to cardiovascular cause or IE recurrence

    Time frame: 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

  9. composite criteria of all-cause mortality, stroke or intracranial hemorrhage, severe hemorrhage as defined by BARC score ≥ 3

    Time frame: 1 year after inclusion

    on-year composite criteria of all-cause mortality, stroke or intracranial hemorrhage, severe hemorrhage as defined by BARC score ≥ 3

  10. composite criteria of all-cause mortality, stroke or intracranial hemorrhage, severe hemorrhage as defined by BARC score ≥ 3

    Time frame: 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

  11. 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

    Time frame: 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

  12. Occurrence of contrast-associated acute kidney injury during the length of hospital stay

    Time frame: up to 90 days after inclusion

    rise of serum creatinine > 26.5 mcmol/L or > 50% elevation from baseline over the course of hospitalization

Study contacts

Contact information is provided by the study sponsor or research team.

Nadjib Hammoudi, MD, PhD

CONTACT

[email protected]

+33 142165535

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: EIPSL

Important dates

Study start
2020
Primary completion
2040
Study completion
2041
First posted
Aug 5, 2021
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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