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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infective Endocarditis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with confirmed IE according to European Society of Cardiology criteria Exclusion Criteria: Opposition of the patient to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause in hospital mortality | All-cause mortality during the length of hospital stay | up to 90 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infective endocarditis, prospective,, prognosis, biomarker, embolism