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

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ClinicalTrials.gov Identifier: NCT01613898
Recruitment Status : Unknown
Verified June 2012 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : June 7, 2012
Last Update Posted : June 7, 2012
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center

Brief Summary:

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 or disease Intervention/treatment
Cerebrotendinous Xanthomatosis (CTX) Biological: Blood tests

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 17 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Carotid IMT and Atherogenic Risk Factors in Patients With Cerebrotendinous Xanthomatosis
Study Start Date : August 2010
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : June 2015


Group/Cohort Intervention/treatment
CTX Group Biological: Blood tests
Blood tests
Other Name: CTX Group



Primary Outcome Measures :
  1. 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 ]

    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


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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01613898     History of Changes
Other Study ID Numbers: SHEBA-09-7393-HC-CTIL
First Posted: June 7, 2012    Key Record Dates
Last Update Posted: June 7, 2012
Last Verified: June 2012

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