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High Density Lipoprotein Subspecies and Coronary Disease

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ClinicalTrials.gov Identifier: NCT00005676
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : March 4, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
To investigate the relative contributions of high density lipoprotein-C (HDL-C) subspecies to risk for coronary heart disease (CHD) in two distinct existing populations (samples from the VA-HIT study and the Framingham Offspring Study [FOS]) as well as the response of these subfractions to gemfibrozil treatment.

Condition or disease
Cardiovascular Diseases Coronary Disease Coronary Arteriosclerosis Heart Diseases

Detailed Description:


Coronary heart disease (CHD) continues to be a leading cause of death and disability in the United States. Information about the contribution of different subspecies of HDL-C to increased or decreased risk for premature CHD and the extent to which common lipoprotein lipase (LPL) mutations affect HDL-C composition and subspecies could contribute to an increased understanding of the role of HDL-C in determining CHD risk.


The following parameters will be measured in blood samples collected from the VA-HIT study and the Framingham Offspring Study: apo A-I-containing HDL subspecies (prebeta, alpha, and prealpha) in plasma using two-dimensional gel electrophoresis immunoblot and image analysis, LpA-I and LpA-I/A-II in plasma using differential electroimmunoassay, and apo C-III in HDL using immunoturbidometric assay. The study hypotheses are as follow. a) Subjects from the placebo arm of VA-HIT will have significantly lower alpha l HDL subspecies, LpA-I, and apo C-III in HDL, and higher HDL/alpha l and apo A-I/alpha l ratios than subjects free of coronary heart disease from the Framingham Offspring Study. b) These parameters will also predict prospectively risk of coronary heart disease in both groups. c) In the VA-HIT study, treatment with gemfibrozil, which has been shown to be associated with a 22 percent reduction in myocardial infarction and coronary heart disease death, will be associated with increases in alpha l HDL subspecies, LpA-I, and apo C-III in HDL, as well as decreases in HDL/alpha l and apo A-I/alpha l ratios, compared to placebo. d) The hypothesis that subjects with specific mutations in the lipoprotein lipase gene have less beneficial changes in HDL subspecies with gemfibrozil than subjects with no mutations will also be tested.

Study Design

Study Type : Observational
Actual Enrollment : 2700 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: High Density Lipoprotein Subspecies and Coronary Disease
Study Start Date : April 2000
Primary Completion Date : August 2005
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

VA-HIT cohort: men with established CHD and low HDL-C FOS cohort: men without CHD

Outcome Measures

Primary Outcome Measures :
  1. HDL subspecies [ Time Frame: 1992-1998 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   41 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
men with CHD and low HDL-C men without CHD
VA-HIT: men, established CHD, HDL-C<40 mg/dl, LDL-C < 140 mg/dl, TG < 300 mg/dl FOS: men having no evidence of CHD
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005676

Sponsors and Collaborators
Tufts University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Bela Asztalos, PhD Tufts University
More Information


Responsible Party: Bela Asztalos, Associate Professor, Tufts University
ClinicalTrials.gov Identifier: NCT00005676     History of Changes
Other Study ID Numbers: 909
R01HL064738 ( U.S. NIH Grant/Contract )
First Posted: May 26, 2000    Key Record Dates
Last Update Posted: March 4, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Vascular Diseases
Arterial Occlusive Diseases