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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00006192
Other study ID # 910
Secondary ID U01HL064244
Status Completed
Phase N/A
First received August 31, 2000
Last updated July 28, 2016
Start date August 2000
Est. completion date December 2005

Study information

Verified date May 2009
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

To document cardiovascular disease and cardiovascular disease risk factors among 1,200 Native Alaskans who are members of approximately 40 families.


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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date December 2005
Est. primary completion date December 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 100 Years
Eligibility No eligibility criteria

Study Design

N/A


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (3)

Carter EA, MacCluer JW, Dyke B, Howard BV, Devereux RB, Ebbesson SO, Resnick HE. Diabetes mellitus and impaired fasting glucose in Alaska Eskimos: the Genetics of Coronary Artery Disease in Alaska Natives (GOCADAN) study. Diabetologia. 2006 Jan;49(1):29-35. Epub 2005 Dec 21. — View Citation

Howard BV, Devereux RB, Cole SA, Davidson M, Dyke B, Ebbesson SO, Epstein SE, Robinson DR, Jarvis B, Kaufman DJ, Laston S, MacCluer JW, Okin PM, Roman MJ, Romenesko T, Ruotolo G, Swenson M, Wenger CR, Williams-Blangero S, Zhu J, Saccheus C, Fabsitz RR, Robbins DC. A genetic and epidemiologic study of cardiovascular disease in Alaska natives (GOCADAN): design and methods. Int J Circumpolar Health. 2005 Jun;64(3):206-21. — View Citation

Nobmann ED, Ponce R, Mattil C, Devereux R, Dyke B, Ebbesson SO, Laston S, MacCluer J, Robbins D, Romenesko T, Ruotolo G, Wenger CR, Howard BV; GOCADAN study, 2000-2003. Dietary intakes vary with age among Eskimo adults of Northwest Alaska in the GOCADAN study, 2000-2003. J Nutr. 2005 Apr;135(4):856-62. — View Citation

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