Research Interest Antiphospholipid in Predicting Embolic Risk During Infective Endocarditis (EMBOL-EI)
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|ClinicalTrials.gov Identifier: NCT02887079|
Recruitment Status : Unknown
Verified August 2016 by Central Hospital, Nancy, France.
Recruitment status was: Recruiting
First Posted : September 1, 2016
Last Update Posted : September 1, 2016
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 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.
|Condition or disease|
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 CEC Nancy 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 AC' anticardiolipin' IgG and IgM isotype by ELISA.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Research Interest Antiphospholipid in Predicting Embolic Risk During Infective Endocarditis|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||May 2018|
- Symptomatic or asymptomatic events occurring before and after IE diagnosis [ Time Frame: at discharge, an average of 8 weeks after inclusion ]By patients have systematic extra-cardiac imaging
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02887079
|Contact: François ALLAfirstname.lastname@example.org|
|Contact: Christine SUTY-SELTONemail@example.com|
|CHU de Besancon||Not yet recruiting|
|Contact: Catherine Chirouze|
|CHU de Nancy||Recruiting|
|Contact: François Alla|