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Trial record 2 of 5 for:    "cerebrotendinous xanthomatosis"

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Sheba Medical Center.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Sheba Medical Center Identifier:
First received: May 22, 2012
Last updated: June 6, 2012
Last verified: June 2012

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 ]

    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


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

Inclusion Criteria:

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

Exclusion Criteria:

  • Non CTX patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01613898

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

Responsible Party: Sheba Medical Center 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

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

Additional relevant MeSH terms:
Xanthomatosis, Cerebrotendinous
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn processed this record on May 25, 2017