Prospective Cohort Study of Patients With Infective Endocarditis at Pitié-Salpêtrière Hospital
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Infective Endocarditis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Cohort Study of Patients With Infective Endocarditis Admitted at Cardiology Institute of 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.
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.
Primary outcome measures
- All-cause in hospital mortality [Time frame: up to 90 days]
Secondary outcome measures (12)
- All-cause mortality [Time frame: an average of 10 years]
- symptomatic or asymptomatic 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 [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 [Time frame: up to 90 days after inclusion]
- heart failure, intracranial hemorrhage, or false vascular aneurysm during hospitalization [Time frame: up to 90 days after inclusion]
- Stroke [Time frame: 90 days after inclusion]
- composite criteria of stroke, Intracranial hemorrhage, hospitalization due to cardiovascular cause or IE recurrence [Time frame: 1 year after inclusion]
- composite criteria of stroke, Intracranial hemorrhage, hospitalization due to cardiovascular cause or IE recurrence [Time frame: through study completion, an average of 10 years]
- composite criteria of all-cause mortality, stroke or intracranial hemorrhage, severe hemorrhage as defined by BARC score ≥ 3 [Time frame: 1 year after inclusion]
- 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]
- 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]
- Occurrence of contrast-associated acute kidney injury during the length of hospital stay [Time frame: up to 90 days after inclusion]
Eligibility criteria
Inclusion criteria
- Patients with confirmed IE according to European Society of Cardiology criteria
Exclusion criteria
- Opposition of the patient to participate
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- APHP Pitié-Salpêtrière Hospital, Department of Cardiology — Paris
Identifiers
NCT: NCT04992923 · APHP200685