Research Interest Antiphospholipid in Predicting Embolic Risk During Infective Endocarditis
EMBOL-EI
1 other identifier
observational
186
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2014
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2015
CompletedFirst Submitted
Initial submission to the registry
July 26, 2016
CompletedFirst Posted
Study publicly available on registry
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2016
CompletedJanuary 11, 2022
December 1, 2021
2 years
July 26, 2016
December 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Eligibility 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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHU de Besancon
Besançon, France
CHU de Nancy
Nancy, France
Related 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 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.
PMID: 29305562RESULT
Biospecimen
serum and plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
July 26, 2016
First Posted
September 1, 2016
Study Start
January 1, 2014
Primary Completion
December 31, 2015
Study Completion
December 31, 2016
Last Updated
January 11, 2022
Record last verified: 2021-12