Evaluation of Carotid IMT and Atherogenic Risk Factors in Patients With Cerebrotendinous Xanthomatosis (CTX)

This study is currently recruiting participants.
Verified June 2012 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01613898
First received: May 22, 2012
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

The aim of the proposed study is to evaluate the risk for cardiovascular disease and 'atherogenic' features of the serum in CTX and to determine preclinical atherosclerosis. The study will include an extensive assessment of lipoprotein profile and carotid artery intima-media thickness (cIMT) measurement.

Lipid and lipoprotein profiles will include novel tests such as direct measurements of apolipoprotein A1,B,C2,C3 plasma levels, lipoprotein (a) levels, highly sensitive C-reactive protein levels and PLAC test that measures the levels of lipoprotein-associated phospholipase A2-a vascular-specific inflammatory enzyme implicated in the formation of atherosclerosis


Condition Intervention
Cerebrotendinous Xanthomatosis (CTX)
Biological: Blood tests

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Carotid IMT and Atherogenic Risk Factors in Patients With Cerebrotendinous Xanthomatosis

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Predisposition of CTX patients for pro-atherogenic features as evaluated by lipid and lipoproteins plasma profiles, and blood chemical assessment. Preclinical atherosclerosis in CTX patients as determined by Carotid artery Intima-media thickness 1. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    The predisposition of the serum of CTX patients to be pro-atherogenic will be evaluated by detailed lipid and lipoproteins plasma profiles, and blood chemical assessment of specific inflammatory pro-atherogenenic features.

    IMT Presence of preclinical atherosclerosis will be determined by Carotid artery Intima-media thickness as a marker of risk for cardiovascular disease.



Biospecimen Retention:   Samples Without DNA

Lipid and lipoprotein profiles


Estimated Enrollment: 17
Study Start Date: August 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CTX Group Biological: Blood tests
Blood tests
Other Name: CTX Group

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

PATIENTS WITH CEREBROTENDINOUS XANTHOMATOSIS

Criteria

Inclusion Criteria:

  • The study population will constitute of all 17 CTX diagnosed patients

Exclusion Criteria:

  • Non CTX patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613898

Locations
Israel
The Bert W. Strassburger Lipid Center Recruiting
Tel Hashomer, Israel, 52621
Contact: tamar luvish, BSN    972-35303492    tamar.luvish@sheba.health.gov.il   
Principal Investigator: Hofit Cohen, Dr.         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Hofit Cohen, MD The Bert W. Strassburger Lipid Center
  More Information

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01613898     History of Changes
Other Study ID Numbers: SHEBA-09-7393-HC-CTIL
Study First Received: May 22, 2012
Last Updated: June 6, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
Cerebrotendinous xanthomatosis (CTX),
lipoprotein,atherosclerosis,
carotid artery intima-media thickness (cIMT).

Additional relevant MeSH terms:
Xanthomatosis
Xanthomatosis, Cerebrotendinous
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on April 22, 2014