NCT00005676

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2000

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2000

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

March 4, 2014

Status Verified

March 1, 2014

Enrollment Period

5.3 years

First QC Date

May 25, 2000

Last Update Submit

March 3, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • HDL subspecies

    1992-1998

Study Arms (1)

VA-HIT and FOS

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

Eligibility Criteria

Age41 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (11)

  • Asztalos BF, Horvath KV, McNamara JR, Roheim PS, Rubinstein JJ, Schaefer EJ. Effects of atorvastatin on the HDL subpopulation profile of coronary heart disease patients. J Lipid Res. 2002 Oct;43(10):1701-7. doi: 10.1194/jlr.m200037-jlr200.

    PMID: 12364554BACKGROUND
  • Asztalos BF, Brousseau ME, McNamara JR, Horvath KV, Roheim PS, Schaefer EJ. Subpopulations of high density lipoproteins in homozygous and heterozygous Tangier disease. Atherosclerosis. 2001 May;156(1):217-25. doi: 10.1016/s0021-9150(00)00643-2.

    PMID: 11369017BACKGROUND
  • Lamon-Fava S, Posfai B, Asztalos BF, Horvath KV, Dallal GE, Schaefer EJ. Effects of estrogen and medroxyprogesterone acetate on subpopulations of triglyceride-rich lipoproteins and high-density lipoproteins. Metabolism. 2003 Oct;52(10):1330-6. doi: 10.1016/s0026-0495(03)00276-2.

    PMID: 14564686BACKGROUND
  • Asztalos BF, Horvath KV, McNamara JR, Roheim PS, Rubinstein JJ, Schaefer EJ. Comparing the effects of five different statins on the HDL subpopulation profiles of coronary heart disease patients. Atherosclerosis. 2002 Oct;164(2):361-9. doi: 10.1016/s0021-9150(02)00149-1.

    PMID: 12204809BACKGROUND
  • Asztalos BF, Batista M, Horvath KV, Cox CE, Dallal GE, Morse JS, Brown GB, Schaefer EJ. Change in alpha1 HDL concentration predicts progression in coronary artery stenosis. Arterioscler Thromb Vasc Biol. 2003 May 1;23(5):847-52. doi: 10.1161/01.ATV.0000066133.32063.BB. Epub 2003 Mar 13.

    PMID: 12637338BACKGROUND
  • Asztalos BF, Cupples LA, Demissie S, Horvath KV, Cox CE, Batista MC, Schaefer EJ. High-density lipoprotein subpopulation profile and coronary heart disease prevalence in male participants of the Framingham Offspring Study. Arterioscler Thromb Vasc Biol. 2004 Nov;24(11):2181-7. doi: 10.1161/01.ATV.0000146325.93749.a8. Epub 2004 Sep 23.

    PMID: 15388521BACKGROUND
  • Batista MC, Welty FK, Diffenderfer MR, Sarnak MJ, Schaefer EJ, Lamon-Fava S, Asztalos BF, Dolnikowski GG, Brousseau ME, Marsh JB. Apolipoprotein A-I, B-100, and B-48 metabolism in subjects with chronic kidney disease, obesity, and the metabolic syndrome. Metabolism. 2004 Oct;53(10):1255-61. doi: 10.1016/j.metabol.2004.05.001.

    PMID: 15375779BACKGROUND
  • Asztalos BF; HDL Atherosclerosis Treatment Study. High-density lipoprotein metabolism and progression of atherosclerosis: new insights from the HDL Atherosclerosis Treatment Study. Curr Opin Cardiol. 2004 Jul;19(4):385-91. doi: 10.1097/01.hco.0000126979.41946.7e.

    PMID: 15218401BACKGROUND
  • Yancey PG, Asztalos BF, Stettler N, Piccoli D, Williams DL, Connelly MA, Rothblat GH. SR-BI- and ABCA1-mediated cholesterol efflux to serum from patients with Alagille syndrome. J Lipid Res. 2004 Sep;45(9):1724-32. doi: 10.1194/jlr.M400133-JLR200. Epub 2004 Jun 21.

    PMID: 15210845BACKGROUND
  • Webb NR, de Beer MC, Asztalos BF, Whitaker N, van der Westhuyzen DR, de Beer FC. Remodeling of HDL remnants generated by scavenger receptor class B type I. J Lipid Res. 2004 Sep;45(9):1666-73. doi: 10.1194/jlr.M400026-JLR200. Epub 2004 Jun 21.

    PMID: 15210842BACKGROUND
  • Asztalos BF, Horvath KV, Kajinami K, Nartsupha C, Cox CE, Batista M, Schaefer EJ, Inazu A, Mabuchi H. Apolipoprotein composition of HDL in cholesteryl ester transfer protein deficiency. J Lipid Res. 2004 Mar;45(3):448-55. doi: 10.1194/jlr.M300198-JLR200. Epub 2003 Dec 1.

    PMID: 14657195BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary DiseaseCoronary Artery DiseaseHeart Diseases

Condition Hierarchy (Ancestors)

Myocardial IschemiaVascular DiseasesArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Bela Asztalos, PhD

    Tufts University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 25, 2000

First Posted

May 26, 2000

Study Start

April 1, 2000

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

March 4, 2014

Record last verified: 2014-03