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

NCT01613898 | Unknown

• 1 other identifier: SHEBA-09-7393-HC-CTIL
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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

Conditions

Cerebrotendinous Xanthomatosis (CTX)

Keywords

Cerebrotendinous xanthomatosis (CTX),; lipoprotein,atherosclerosis,; carotid artery intima-media thickness (cIMT).

Outcome Measures

Primary Outcomes (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.

  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.

  3 years

Study Arms (1)

CTX Group

Biological: Blood tests

Interventions

Blood tests BIOLOGICAL

Blood tests

Also known as: CTX Group

CTX Group

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

PATIENTS WITH CEREBROTENDINOUS XANTHOMATOSIS

You may qualify if:

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

You may not qualify if:

• Non CTX patients

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

The Bert W. Strassburger Lipid Center

Tel Litwinsky, 52621, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Lipid and lipoprotein profiles

MeSH Terms

Conditions

Xanthomatosis, Cerebrotendinous; Atherosclerosis

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Xanthomatosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Hofit Cohen, MD

  The Bert W. Strassburger Lipid Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2012
• First Posted: June 7, 2012
• Study Start: August 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2015
• Last Updated: June 7, 2012

Record last verified: 2012-06

Locations

IL (1)