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DARK STUDY "DysbetalipoproteinemiA and atheRoma Risk"

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Unknown status
CT.gov ID
NCT01760265
Collaborator
(none)
50
Enrollment
1
Location
5
Duration (Months)
10.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Dysbetalipoproteinemia (type III, Fredrickson's classification) is a rare metabolic disorder. It results from a defect in the clearance of VLDL and chylomicron remnants due to homozygous APOE2 variants or heterozygous APOE mutations, and there is an elevated plasma cholesterol and triglycerides.

As a consequence of the derangements in lipoprotein metabolism, dysbetalipoproteinemia predispose to the premature development of atherosclerosis.

However among this population there is heterogeneity in development of cardiovascular complications and the determinants remain unclear actually.

The aim of the investigators study is to evaluate the intensity of clinical atherosclerosis, and identify its determinants.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Dysbetalipoproteinemia and Atheroma Risk : Assessment of Cardiovascular Risk in Dysbetalipoproteinemic Patients
    Study Start Date :
    Jan 1, 2013
    Anticipated Primary Completion Date :
    Jun 1, 2013
    Anticipated Study Completion Date :
    Jun 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. Computed tomographic measurements for coronary-artery calcium [Day one : the coronary calcium score is assessed on the date of measurement]

      Comparison with eventual previous examinations.

    Secondary Outcome Measures

    1. Measurement of carotid intima-media by ultrasonography [Day one : on the date of measurement]

      Comparison with eventual previous examinations.

    2. Measurement of ankle brachial index [Day one : on the date of measurement]

      Comparison with eventual previous examinations

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • apo E gene sequencing in CBE (Centre de Biologie Est / Hospices Civils de Lyon / France) laboratory in Lyon until December 2012
    Exclusion Criteria:

    • age < 40 years

    • refused participation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospices Civils de Lyon - Groupement Hospitalier Est Bron France 69100

    Sponsors and Collaborators

    • Hospices Civils de Lyon

    Investigators

    • Principal Investigator: Philippe MOULIN, Pr, Hospices Civils de Lyon

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hospices Civils de Lyon
    ClinicalTrials.gov Identifier:
    NCT01760265
    Other Study ID Numbers:
    • 1
    First Posted:
    Jan 4, 2013
    Last Update Posted:
    Jan 28, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by Hospices Civils de Lyon
    dysbetalipoproteinemia
    artery calcium score
    carotid intima media
    ankle brachial index
    dysbetalipoproteinemic patients
    Additional relevant MeSH terms:
    Hyperlipoproteinemia Type III
    Plaque, Atherosclerotic

    Study Results

    No Results Posted as of Jan 28, 2013