Research Interest Antiphospholipid in Predicting Embolic Risk During Infective Endocarditis (EMBOL-EI)
EMBOL-EI (Research Interest antiphospholipid antibody for embolic risk prediction in infective endocarditis) is a prospective cohort study with a biological collection.
The main objective is: to re-evaluate the potential value of antiphospholipid (aPL) antibodies as predictors of embolic events in infective endocarditis (IE) in the light of the improved current knowledge on these aPL.
The seconds objectives are: Other plasma biomarkers of hemostasis (coagulation activation markers: D-dimer fragment 1 + 2 of prothrombin; endothelial biomarkers: plasma levels of von Willebrand factor) will be taken into account in the analysis, and interest in predicting embolic risk, alone or in combination with aPL will be investigated.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Criteria of inclusion
- Patient hospitalized in the University Hospital of Nancy with an Endocarditis some as modified Duke criteria by Li.
The patient is eligible if it is considered and treated as a case of infective endocarditis by physicians ensuring its management. The application of the diagnostic classification Duke criteria modified by Li is made after the collection of all the data at the output of the patient. Will be retained for the analysis of patients meeting certain infective endocarditis.
Clinical, microbiological data, derived from complementary therapies and scalable examinations (including the endpoint) were collected during the hospital stay by doctors that support helped a patient technician clinical studies. Each application is reviewed by a multidisciplinary panel of two experts for validation.
Once validated record, the data collection schedule is sent to the Centre d'Investigation Clinique 1433 Epidémiologie Clinique (CIC-EC) to be entered on a database.
A blood sample is taken from each patient at admission. These samples are packaged and stored in a collection. The serum used in search - called anticardiolipin (AC) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) isotype by ELISA.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Besancon, Frankrig
- CHU de Besancon
-
Nancy, Frankrig
- Chu de Nancy
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- All the patients admitted either in the Infectious Department, in the Cardiology Department or in the Intensive Care Unit of the University Hospital of Nancy and treated for IE.
Exclusion Criteria:
- Patients with a previously known aPL syndrome or illness frequently associated with aPL syndrome (such as lupus)
- Patients with a delay between blood sample and diagnosis of IE longer than 21days
- Patients who had no symptomatic embolic events and no imaging procedure to detect an asymptomatic embolic event
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Symptomatic or asymptomatic events occurring before and after IE diagnosis
Tidsramme: at discharge, an average of 8 weeks after inclusion
|
By patients have systematic extra-cardiac imaging
|
at discharge, an average of 8 weeks after inclusion
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PHRCI 2013-13087
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Infektiøs endokarditis
-
Montreal Heart InstituteRekrutteringInfektiøs endokarditis | Native Valve EndocarditisCanada
-
Region SkaneAfsluttet
-
University of PennsylvaniaTrukket tilbageStaphylococcus Aureus Bakteriæmi | Staphylococcus Aureus EndocarditisForenede Stater
-
ContraFectAfsluttetStaphylococcus Aureus Bakteriæmi | Staphylococcus Aureus EndocarditisForenede Stater, Belgien, Bulgarien, Chile, Tjekkiet, Frankrig, Tyskland, Grækenland, Guatemala, Israel, Italien, Den Russiske Føderation, Spanien, Det Forenede Kongerige
-
ContraFectAfsluttetStaphylococcus Aureus Bakteriæmi | Staphylococcus Aureus EndocarditisForenede Stater
-
Todd C. Lee MD MPH FIDSAIkke rekrutterer endnuStaphylococcus Aureus Bakteriæmi | Staphylococcus Aureus Endocarditis | Staphylococcus Aureus Septikæmi | Staphylococcus sepsisCanada