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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00005184
Other study ID # 1062
Secondary ID R01HL033959
Status Completed
Phase N/A
First received May 25, 2000
Last updated May 12, 2016
Start date December 1985
Est. completion date November 1989

Study information

Verified date May 2000
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 assess the association of immunogenetic factors with onset of coronary heart disease and the interrelationship of these factors with standard coronary heart disease risk factors.


Description:

BACKGROUND:

Although the familial clustering of coronary heart disease has been well documented, it is unclear as to whether the familial clustering can be explained by shared environmental factors by members of a family or by clustering of risk factors having a genetic component such as blood pressure, familial hyperlipidemia and/or diabetes. Studies indicate that a family history of coronary disease may be an independent risk factor. Major histocompatibility complex genetic markers to identify individuals at risk within a family may be useful. In 1985 when the study began, there was a paucity of data dealing with the interrelationship of family history, genetic markers, immunological markers, and traditional risk factors.

DESIGN NARRATIVE:

In this case-control study, the study population consisted of incident cases who presented to the Georgia Heart Clinic in La Grange, Georgia with coronary heart disease. The majority of the subjects were from three counties in mideastern Alabama and from counties in midwestern Georgia. All subjects had undergone diagnostic coronary angiography. A determination was made in patients and controls of the association of major histocompatibility complex genetic markers HLA-A, -B, -C, -DR, C4 and BF, C3, the restriction fragment length polymorphisms (RFLP's) flanking the apolipoprotein AI and insulin genes, presence of autoantibodies, and family history of coronary disease, diabetes, or hypothyroidism. The frequency of these variables was compared with the standard coronary risk factors of family history, hypertension, lipid abnormalities, lifestyle, Type A behavior, obesity and with diseases such as diabetes and hypothyroidism. An analysis was made of the strength of these variables for predicting those individuals at risk and whether there were variables which predict severity of disease based on 1, 2, or 3 vessel involvement.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date November 1989
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group N/A 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 (4)

Acton R, Bamberg R, Go R, Roseman J: Utilization of Genetic and Other Laboratory Test Results to Predict and Reduce the Risk of Disease. In: Proceedings of the Society of Prospective Medicine, 1988. 1988.

Bamberg R, Copeland R, Barger B, Roseman J, Go R, Vanichanan C, Brand J, Moore P, Acton R: Genetic Risk Information as an Impetus to Health Related Behavioral Change. In: Proceedings of the Society of Prospective Medicine, 1988. 1988.

Go R, Acton R, Roseman J, Barger B, Perkins L, Vanichanan T, Moore P, Brand J, Gore T, Brennan J, Cousins L, Copeland R: Immunogenetic Risk Factors for Premature Coronary Artery Disease in Southeastern USA Population. Genome, 30:34, 1988

Pancharuniti N, Lewis CA, Sauberlich HE, Perkins LL, Go RC, Alvarez JO, Macaluso M, Acton RT, Copeland RB, Cousins AL, et al. Plasma homocyst(e)ine, folate, and vitamin B-12 concentrations and risk for early-onset coronary artery disease. Am J Clin Nutr. 1994 Apr;59(4):940-8. Erratum in: Am J Clin Nutr 1996 Apr;63(4):609. — View Citation

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