High Density Lipoprotein Subspecies and Coronary Disease

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bela Asztalos, Tufts University
ClinicalTrials.gov Identifier:
NCT00005676
First received: May 25, 2000
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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
Cardiovascular Diseases
Coronary Disease
Coronary Arteriosclerosis
Heart Diseases

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: High Density Lipoprotein Subspecies and Coronary Disease

Resource links provided by NLM:


Further study details as provided by Tufts University:

Primary Outcome Measures:
  • HDL subspecies [ Time Frame: 1992-1998 ] [ Designated as safety issue: No ]

Enrollment: 2700
Study Start Date: April 2000
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts
VA-HIT and FOS
VA-HIT cohort: men with established CHD and low HDL-C FOS cohort: men without CHD

Detailed Description:

BACKGROUND:

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.

DESIGN NARRATIVE:

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.

  Eligibility

Ages Eligible for Study:   41 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

men with CHD and low HDL-C men without CHD

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00005676

Sponsors and Collaborators
Tufts University
Investigators
Principal Investigator: Bela Asztalos, PhD Tufts University
  More Information

Publications:

Responsible Party: Bela Asztalos, Associate Professor, Tufts University
ClinicalTrials.gov Identifier: NCT00005676     History of Changes
Other Study ID Numbers: 909, R01HL064738
Study First Received: May 25, 2000
Last Updated: March 3, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on July 29, 2014