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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02887079
Recruitment Status : Completed
First Posted : September 1, 2016
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Christine Selton-Suty, Central Hospital, Nancy, France

Study Description
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Brief 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.


Condition or disease
Infective Endocarditis

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.

Study Design
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Study Type : Observational
Actual Enrollment : 186 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Research Interest Antiphospholipid in Predicting Embolic Risk During Infective Endocarditis
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endocarditis

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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
serum and plasma

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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France
CHU de Besancon
Besancon, France
CHU de Nancy
Nancy, France
Sponsors and Collaborators
Central Hospital, Nancy, France
More Information
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Publications of Results:

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Responsible Party: Christine Selton-Suty, Dr, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02887079    
Other Study ID Numbers: PHRCI 2013-13087
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: December 2021
Additional relevant MeSH terms:
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Endocarditis, Bacterial
Endocarditis
Heart Diseases
Cardiovascular Diseases
 Bacterial Infections
Bacterial Infections and Mycoses
Infections
Cardiovascular Infections