Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT00584467
Status:
TERMINATED
Last Update Posted:
2018-01-31
First Post:
2007-12-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Genetic and Inflammatory Markers in Cardiovascular Disease (GEM) Registry
Sponsor:
University of California, Davis
Organization:
Study Overview
Official Title:
Genetic and Inflammatory Markers in Cardiovascular Disease (GEM) Registry
Status:
TERMINATED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GEM
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: