Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-26 @ 10:28 PM
Study NCT ID:
NCT00006192
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2000-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetics of Coronary Artery Disease in Alaskan Natives (GOCADAN)
Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-05
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:
None
Brief Summary:
To document cardiovascular disease and cardiovascular disease risk factors among 1,200 Native Alaskans who are members of approximately 40 families.
Detailed Description:
BACKGROUND:
There are many compelling reasons to study heart disease in the Native Alaskans. These Eskimo villages are remote and isolated. The traditional lifestyle is being eroded by mechanization and a westernized diet. There has been relatively little outside genetic influence and they are, like the American Indians of the lower 48 states, beginning to show a marked acceleration in the prevalence of atherosclerosis and coronary artery disease.
DESIGN NARRATIVE:
The study is a family-based, cross sectional study. Recognized and emerging risk factors and prevalent cardiovascular disease are documented in each individual through a standardized interview, physical exam, laboratory measurements, carotid ultrasound, ECG, and a review of centralized medical records. Assays will be made of contemporary samples and serum specimens stored at the Anchorage Center CDC antedating this study (10 to 20 years ago) for specific markers of inflammation and serologic responses. Through a ten-centimorgan genetic map, attempts will be made to find specific genes that relate to cardiovascular disease.
The study uses standard methods to assess risk factors relating to lipid metabolism, hypertension, and diabetes mellitus. Importantly, the study also uses state-of-the-art methods for detection of infectious disease exposure, specifically to C. pneumoniae, cytomegalovirus, and other infectious agents hypothesized to play a role in atherogenesis. A case-control age-matched design is used to analyze the infectious disease burden.
There are many compelling reasons to study heart disease in the Native Alaskans. These Eskimo villages are remote and isolated. The traditional lifestyle is being eroded by mechanization and a westernized diet. There has been relatively little outside genetic influence and they are, like the American Indians of the lower 48 states, beginning to show a marked acceleration in the prevalence of atherosclerosis and coronary artery disease.
DESIGN NARRATIVE:
The study is a family-based, cross sectional study. Recognized and emerging risk factors and prevalent cardiovascular disease are documented in each individual through a standardized interview, physical exam, laboratory measurements, carotid ultrasound, ECG, and a review of centralized medical records. Assays will be made of contemporary samples and serum specimens stored at the Anchorage Center CDC antedating this study (10 to 20 years ago) for specific markers of inflammation and serologic responses. Through a ten-centimorgan genetic map, attempts will be made to find specific genes that relate to cardiovascular disease.
The study uses standard methods to assess risk factors relating to lipid metabolism, hypertension, and diabetes mellitus. Importantly, the study also uses state-of-the-art methods for detection of infectious disease exposure, specifically to C. pneumoniae, cytomegalovirus, and other infectious agents hypothesized to play a role in atherogenesis. A case-control age-matched design is used to analyze the infectious disease burden.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U01HL064244 | NIH | None | https://reporter.nih.gov/quic… | View |