Genetic and Inflammatory Markers in Cardiovascular Disease (GEM) Registry

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of California, Davis.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00584467
First received: December 26, 2007
Last updated: June 4, 2008
Last verified: June 2008
  Purpose

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
Atherosclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetic and Inflammatory Markers in Cardiovascular Disease (GEM) Registry

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Biospecimen Retention:   Samples With DNA

blood/serum


Enrollment: 21
Study Start Date: January 2005
Estimated Study Completion Date: November 2009
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584467

Sponsors and Collaborators
University of California, Davis
University of California, San Francisco
Investigators
Principal Investigator: Jason Rogers, MD University of California, Davis
  More Information

Additional Information:
No publications provided

Responsible Party: Jason H. Rogers, MD, University of California, Davis Medical Center
ClinicalTrials.gov Identifier: NCT00584467     History of Changes
Other Study ID Numbers: 200513134
Study First Received: December 26, 2007
Last Updated: June 4, 2008
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of California, Davis:
GEM
Arteriosclerosis
biomarkers
Atherosclerosis

Additional relevant MeSH terms:
Atherosclerosis
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014