Biomarkers in Vascular Ehlers-Danlos Syndrome
MEDIC
Identification of Plasmatic Biomarkers in Vascular Ehlers-Danlos Syndrome
1 other identifier
observational
211
1 country
1
Brief Summary
The purpose of this study is to determine whether patients with vascular Ehlers-Danlos syndrome present significant and specific changes of arterial endothelial and smooth muscular cell signalling/secretion, in comparison to matched healthy volunteers and patients with spontaneous arterial dissections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2013
Typical duration for all trials
1 active site
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
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 7, 2014
CompletedFirst Posted
Study publicly available on registry
June 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedMarch 17, 2016
March 1, 2016
2.1 years
May 7, 2014
March 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic value of plasma biomarkers SEDv
Analysis of the diagnostic value of different levels of plasma concentrations of microRNAs
At the end of study (2 years after period of inclusion for first patient)
Secondary Outcomes (1)
Reference value of biomarkers
At the end of study (2 years after period of inclusion for first patient)
Study Arms (3)
Vascular-Ehlers Danlos syndrome
N=50 patients with vascular Ehlers-Danlos syndrome
Spontaneous arterial dissection(s)
N=50 patients
Healthy volunteers
n=100 Healthy volunteers
Eligibility Criteria
Patients with vascular Ehlers-Danlos syndrome and patients with spontaneous dissection(s) will be recruited from the French National Referral Centre for Rare arterial diseases, Hopital Europeen Georges Pompidou, Paris, France. Healthy volunteers will be recruited by the clinical investigations center, Hopital Europeen Georges Pompidou, Paris, France (random community sample).
You may qualify if:
- Patients with vascular Ehlers-Danlos syndrome must have been positively tested for a pathogenic mutation within the COL3A1 gene.
- In patients with arterial dissection(s) any associated systemic arterial disease must have been ruled out, especially vascular Ehers-Danlos syndrome
You may not qualify if:
- All subjects must not present any chronic systemic disease, any acute disease within seven days prior to enrollment, diabetes mellitus and arterial hypertension.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hopital europeen Georges Pompidou
Paris, 75015, France
Related Publications (1)
Morissette R, Schoenhoff F, Xu Z, Shilane DA, Griswold BF, Chen W, Yang J, Zhu J, Fert-Bober J, Sloper L, Lehman J, Commins N, Van Eyk JE, McDonnell NB. Transforming growth factor-beta and inflammation in vascular (type IV) Ehlers-Danlos syndrome. Circ Cardiovasc Genet. 2014 Feb;7(1):80-8. doi: 10.1161/CIRCGENETICS.113.000280. Epub 2014 Jan 6.
PMID: 24399159BACKGROUND
Related Links
Biospecimen
Serum, Plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Frank, MD
Centre de Reference des Maladies Vasculaires Rares, Hopital Europeen Georges Pompidou, APHP, Paris France
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2014
First Posted
June 17, 2014
Study Start
June 1, 2013
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
March 17, 2016
Record last verified: 2016-03