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Hyperapo B and Coronary Heart Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005168
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : February 18, 2016
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
To determine the role of apolipoprotein B and apolipoprotein A1 in the etiology of coronary artery disease.

Condition or disease
Cardiovascular Diseases Coronary Disease Heart Diseases Diabetes Mellitus Obesity Hypercholesterolemia, Familial

Detailed Description:


Hyperapo B is a phenotype defined as elevated plasma level of the major apoprotein B of low density lipoproteins in the presence of a normal plasma level of low density lipoprotein cholesterol. It has been demonstrated that hyperapo B is strongly associated with coronary artery disease. In 1984 when the study began, the independence of this association with other risk factors for coronary artery disease such as cigarette smoking, hypertension, and low plasma levels of high density lipoproteins was not known. The study improved knowledge of the pathophysiology of coronary artery disease and of the genetic and biochemical defects of hyperapo B and hypoalphalipoproteinemia.


Interviews were conducted and clinical data collected on each index case and spouse, as well as on first degree relatives. Risk factor data included blood pressure, blood lipid levels, obesity, cigarette smoking, fasting blood sugar and diabetes, hormone use and menopause for women, physical activity, personality scores, and family history. Clinical data included the indications for coronary arteriography, history of use of lipid-lowering agents and insulin, presence of corneal arcus, xanthomata, and xanthelasma, and the electrocardiogram.

To determine if the apolipoprotein B gene and the apolipoprotein A1-C3-A4 gene cluster were independent predictors of premature coronary disease, the relation between DNA polymeric sites within the two genes and coronary disease were investigated using cloned DNA fragments as molecular probes. To determine if apolipoprotein B and apolipoprotein A levels aggregated in families and to determine if hyperapo B and hypoalphalipoproteinemia segregated as Mendelian traits, genetic analysis was conducted in the 200 index cases and the 900 first degree relatives. Studies were also conducted on the linkages between hyperapo B and haplotypes of the apolipoprotein B gene, on hyperapo B and the Ag polymorphisms, and on hyperalphalipoproteinemia and haplotypes of the apolipoprotein A1-C3-A4 gene cluster.

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

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Study Type : Observational
Study Start Date : August 1984
Actual Study Completion Date : December 1991

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
No eligibility criteria
Sniderman A, Kwiterovich PO Jr: Hyperapobetalipoproteinemia and LDL and HDL2 Heterogenity. Proceedings of the Workshop on Lipoprotein Heterogeneity, U.S. Department of Health and Human Services, NIH Publication No. 87-2646, pp 293-304, 1987

Layout table for additonal information Identifier: NCT00005168    
Other Study ID Numbers: 1042
R01HL031497 ( U.S. NIH Grant/Contract )
First Posted: May 26, 2000    Key Record Dates
Last Update Posted: February 18, 2016
Last Verified: May 2000
Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Coronary Disease
Hyperlipoproteinemia Type II
Lipid Metabolism Disorders
Metabolic Diseases
Myocardial Ischemia
Vascular Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn