Genetic and Inflammatory Markers in Cardiovascular Disease (GEM) Registry

Terminated

• Conditions: Atherosclerosis

• Registration Number: NCT00584467
• Lead Sponsor: University of California, Davis

Brief Summary

This is an investigator initiated registry aimed at assembling a blood/serum and genomic resource (bank) of human blood samples with accompanying clinical data mainly from patients who are scheduled to undergo cardiac catheterization at UC Davis Medical Center, but may also include other eligible individuals. Funding is from institutional/divisional research funds.

Detailed Description

This study is aimed at assembling a blood/serum and genomic resource (bank) of human samples with accompanying clinical data mainly from patients who are scheduled to undergo cardiac catheterization at UC Davis Medical Center, but may also include other eligible individuals. These samples will be analyzed at UC Davis Medical Center for determination of biomarker levels, and concomitantly analyzed at UC San Francisco in an IRB-approved protocol at that institution for genetic analysis (UCSF IRB approval # for this study is H711-15138-03; protocol name is "Discovery of Gene Mutations and Polymorphisms that Contribute to the Risk of Atherosclerosis"; principal investigator is John P. Kane, MD). All samples sent to UCSF will be de-identified and catalogued using an alphanumeric code. A number of candidate genes will be studied to detect mutations and polymorphisms that could contribute to the risk of atherosclerosis. The technique of hybridization sequencing will be employed for this. The techniques of classical statistical genetics will be employed for both cosegregation analysis and for the genome search approach. Clinical follow-up may be obtained at 6 and 12 months.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2008-01-02
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-29
• Last Update Posted: 2018-01-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Any individual cared for in the UC Davis Health System
• disorders of lipoproteins or arteriosclerosis

Exclusion Criteria

• Subjects will be excluded only if they refuse to be in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified