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

Overview

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.

Full Title of Study: “Prospective Cohort Study of Patients With Infective Endocarditis Admitted at Cardiology Institute of Pitié-Salpêtrière Hospital”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2040

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.

Clinical Trial Outcome Measures

Primary Measures

  • All-cause in hospital mortality
    • Time Frame: up to 90 days
    • All-cause mortality during the length of hospital stay

Secondary Measures

  • All-cause mortality
    • Time Frame: an average of 10 years
    • mortality at longest follow-up
  • 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
  • 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
  • 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
  • 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
  • Stroke
    • Time Frame: 90 days after inclusion
    • Stroke during the length of hospital stay
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Participating in This Clinical Trial

Inclusion Criteria

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

  • Opposition of the patient to participate

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Nadjib Hammoudi, MD, PhD, Principal Investigator, Pitié- Salpêtrière Hospital (AP-HP)
  • Overall Contact(s)
    • Nadjib Hammoudi, MD, PhD, +33 142165535, nadjib.hammoudi@aphp.fr

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