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Sponsors and Collaborators: |
University of California, Davis University of California, San Francisco |
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Information provided by: | University of California, Davis |
ClinicalTrials.gov Identifier: | NCT00584467 |
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.
Condition |
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Atherosclerosis |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Genetic and Inflammatory Markers in Cardiovascular Disease (GEM) Registry |
blood/serum
Enrollment: | 21 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | November 2009 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Subjects will mainly include individuals who are scheduled to undergo cardiac catheterization at UC Davis Medical Center, but may include other eligible individuals. Subjects may also include individuals who have objective evidence of the extent of arteriosclerosis of the coronary, femoral or carotid arteries.
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | University of California, Davis Medical Center ( Jason H. Rogers, MD ) |
Study ID Numbers: | 200513134 |
Study First Received: | December 26, 2007 |
Last Updated: | June 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00584467 History of Changes |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
GEM Arteriosclerosis biomarkers Atherosclerosis |
Arterial Occlusive Diseases Atherosclerosis Vascular Diseases Arteriosclerosis |
Arterial Occlusive Diseases Atherosclerosis Vascular Diseases Cardiovascular Diseases Arteriosclerosis |