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VLDL and LDL Particle Types as Coronary Heart Disease Risk Factors

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Frank M. Sacks, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00065793
First received: July 31, 2003
Last updated: January 29, 2013
Last verified: January 2013

July 31, 2003
January 29, 2013
July 2003
June 2008   (final data collection date for primary outcome measure)
apoB concentration of LDL with apoC-III [ Time Frame: 10-14 years ] [ Designated as safety issue: No ]
observational follow-up for coronary events
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Complete list of historical versions of study NCT00065793 on ClinicalTrials.gov Archive Site
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VLDL and LDL Particle Types as Coronary Heart Disease Risk Factors
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To evaluate very low density lipoprotein (VLDL) and low density lipoprotein (LDL) particle types as predictors of initial coronary events.

BACKGROUND:

Plasma triglyceride concentration is an independent although relatively weak risk factor for coronary heart disease (CHD). The relative weakness of plasma triglycerides to predict CHD may be due to the substantial diversity of lipoprotein particles that carry the triglycerides, some being related to atherosclerosis and CHD more than others. The investigators have shown in patients who have had a myocardial infarction that the rather weak association between triglycerides and subsequent coronary events is secondary to a stronger relationship with specific types of VLDL remnants, those in the LDL density range that contain apoCIIl.

DESIGN NARRATIVE:

The study will evaluate VLDL and LDL particle types as predictors of initial coronary events in men from the Health Professional Follow-up Study (HPFS) and women from the Nurses Health Study (NHS). A prospective nested case-control design will be used with a total of 1000 CHD cases and 1000 matched controls, with equal numbers of men and women. The investigators will specifically investigate the role of apoCIII containing VLDL and LDL particles in diabetes by over sampling so that 50% of the patients will have type 2 diabetes mellitus. Their previous work shows that LDL apoCIII particles are independent predictors of recurrent CHD in diabetic patients who survived a myocardial infarction. They hypothesize that apoCIII may have a special role in dyslipidemia and CHD in diabetes. Secondary Aims: Besides apoCIII, other small apolipoproteins, apo C1, CII, and All are components of VLDL and LDL and modulate the metabolism of apoB lipoproteins. It is likely that these apolipoproteins have a relationship with human atherosclerosis. They will measure these apolipoproteins in VLDL and LDL and evaluate their relationship to CHD. They will also investigate the associations between these new lipoprotein risk factors and intake of foods and nutrients, physical activity, and other risk factors, including smoking, BMI, age and gender. The results will provide new means to identify nondiabetic and diabetic persons who are at high risk of developing CHD and the environmental determinants, and could form the basis for new lipoprotein targets for lipid management by diet and medicines.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Nurses Health Study Health Professionals Follow-up Study

  • Cardiovascular Diseases
  • Heart Diseases
  • Coronary Disease
  • Myocardial Infarction
  • Diabetes Mellitus
  • Diabetes Mellitus, Non-insulin Dependent
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1478
June 2008
June 2008   (final data collection date for primary outcome measure)

Cases having first coronary event

Both
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Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00065793
1232, R01HL070159
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Frank M. Sacks, Brigham and Women's Hospital
Brigham and Women's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Frank Sacks, MD Harvard School of Public Health
Principal Investigator: Frank Sacks, MD Brigham and Women's Hospital
Brigham and Women's Hospital
January 2013

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