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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

May 25, 2000
March 3, 2014
April 2000
August 2005   (final data collection date for primary outcome measure)
HDL subspecies [ Time Frame: 1992-1998 ] [ Designated as safety issue: No ]
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
Not Provided
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

Male
41 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00005676
909, R01HL064738
No
Bela Asztalos, Tufts University
Tufts University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Bela Asztalos, PhD Tufts University
Tufts University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP