Infective Endocarditis
Conditions
Keywords
Infective endocarditis, prospective,, prognosis, biomarker, embolism
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.
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.
Interventions
None listed
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with confirmed IE according to European Society of Cardiology criteria
Exclusion criteria
* Opposition of the patient to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause in hospital mortality | up to 90 days | All-cause mortality during the length of hospital stay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| symptomatic or asymptomatic systemic embolism | 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 | 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 |
| heart failure, intracranial hemorrhage, or false vascular aneurysm during hospitalization | up to 90 days after inclusion | Occurrence of heart failure, intracranial hemorrhage, or false vascular aneurysm during the length of hospital stay |
| Stroke | 90 days after inclusion | Stroke during the length of hospital stay |
| All-cause mortality | an average of 10 years | mortality at longest follow-up |
| composite criteria of all-cause mortality, stroke or intracranial hemorrhage, severe hemorrhage as defined by BARC score ≥ 3 | 1 year after inclusion | on-year 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 | 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 | up to 90 days after inclusion | rise of serum creatinine \> 26.5 mcmol/L or \> 50% elevation from baseline over the course of hospitalization |
| composite criteria of stroke, Intracranial hemorrhage, hospitalization due to cardiovascular cause or IE recurrence | 1 year after inclusion | Occurrence of a composite criteria of stroke, Intracranial hemorrhage, hospitalization due to cardiovascular cause or IE recurrence at one year |
Countries
France
Contacts
Primary ContactNadjib Hammoudi, MD, PhD
Outcome results
None listed