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CompletedNCT02887079EMBOL-EIUpdated Jan 11, 2022

Research Interest Antiphospholipid in Predicting Embolic Risk During Infective Endocarditis

An observational study in Infective Endocarditis, sponsored by Central Hospital, Nancy, France. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-11.

Sponsored by Central Hospital, Nancy, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
186
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed 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.

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Conditions studied

  • Infective Endocarditis

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03

In context

Endocarditis

173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.

This study's enrollment of 186 is below the median of 225 across 82 observational studies indexed under Endocarditis.

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Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
186 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. Symptomatic or asymptomatic events occurring before and after IE diagnosis

    By patients have systematic extra-cardiac imaging

    Time frame: at discharge, an average of 8 weeks after inclusion

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Study locations

2 sites
  • CHU de Besancon
    Besancon, France
  • CHU de Nancy
    Nancy, France
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References and documents

Publications

  • 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 antiphospholipid antibodies and embolic events in infective endocarditis. Heart. 2018 Mar;104(6):509-516. doi: 10.1136/heartjnl-2017-312359. Epub 2018 Jan 5. PubMed 29305562 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02887079
Responsible party
Christine Selton-Suty (Dr, Central Hospital, Nancy, France) — Principal investigator
First posted
Sep 1, 2016
Start date
Jan 1, 2014
Primary completion
Dec 31, 2015
Completion
Dec 31, 2016
Last update
Jan 11, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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