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High Density Lipoprotein Subspecies and Coronary Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005676
First Posted: May 26, 2000
Last Update Posted: March 4, 2014
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.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Bela Asztalos, Tufts University
May 25, 2000
May 26, 2000
March 4, 2014
April 2000
August 2005   (Final data collection date for primary outcome measure)
HDL subspecies [ Time Frame: 1992-1998 ]
Not Provided
Complete list of historical versions of study NCT00005676 on ClinicalTrials.gov Archive Site
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High Density Lipoprotein Subspecies and Coronary Disease
High Density Lipoprotein Subspecies and Coronary Disease
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Probability Sample
men with CHD and low HDL-C men without CHD
  • Cardiovascular Diseases
  • Coronary Disease
  • Coronary Arteriosclerosis
  • Heart Diseases
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VA-HIT and FOS
VA-HIT cohort: men with established CHD and low HDL-C FOS cohort: men without CHD

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2700
August 2005
August 2005   (Final data collection date for primary outcome measure)
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
Sexes Eligible for Study: Male
41 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00005676
909
R01HL064738 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Bela Asztalos, Tufts University
Tufts University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Bela Asztalos, PhD Tufts University
Tufts University
March 2014