- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01760265
DARK STUDY "DysbetalipoproteinemiA and atheRoma Risk" (DARK)
Dysbetalipoproteinemia and Atheroma Risk : Assessment of Cardiovascular Risk in Dysbetalipoproteinemic Patients
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Philippe MOULIN, Pr
- Phone Number: +33 4 72 68 13 04
- Email: philippe.moulin@chu-lyon.fr
Study Locations
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-
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Bron, France, 69100
- Recruiting
- Hospices Civils de Lyon - Groupement Hospitalier Est
-
Contact:
- Philippe MOULIN
- Phone Number: +33 4 72 68 13 04
- Email: Philippe.moulin@chu-lyon.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Computed tomographic measurements for coronary-artery calcium
Time Frame: Day one : the coronary calcium score is assessed on the date of measurement
|
Comparison with eventual previous examinations.
|
Day one : the coronary calcium score is assessed on the date of measurement
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of carotid intima-media by ultrasonography
Time Frame: Day one : on the date of measurement
|
Comparison with eventual previous examinations.
|
Day one : on the date of measurement
|
Measurement of ankle brachial index
Time Frame: Day one : on the date of measurement
|
Comparison with eventual previous examinations
|
Day one : on the date of measurement
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philippe MOULIN, Pr, Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1
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