Research Interest Antiphospholipid in Predicting Embolic Risk During

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02887079
Study type	Observational
Source	Central Hospital, Nancy, France
Contact
Status	Completed
Phase
Start date	January 1, 2014
Completion date	December 31, 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Research Interest Antiphospholipid in Predicting Embolic Risk During Infective Endocarditis — EMBOL-EI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms