Research Interest Antiphospholipid in Predicting Embolic Risk During Infective Endocarditis

Infective Endocarditis Clinical Trial

— EMBOL-EI  

Official title:

Research Interest Antiphospholipid in Predicting Embolic Risk During Infective Endocarditis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02887079
• Other study ID #: PHRCI 2013-13087
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: December 31, 2016

Study information

• Verified date: December 2021
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis

Locations

Country	Name	City	State
France	CHU de Besancon	Besancon
France	CHU de Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (1)

Selton-Suty C, Maigrat CH, Devignes J, Goehringer F, Erpelding ML, Alla F, Thivilier C, Huttin O, Venner C, Juilliere Y, Doco-Lecompte T, Lecompte T; Endocarditis Team of the University Hospital of Nancy, France. Possible relationship between antiphosphol — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptomatic or asymptomatic events occurring before and after IE diagnosis	By patients have systematic extra-cardiac imaging	at discharge, an average of 8 weeks after inclusion