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VLDL and LDL Particle Types as Coronary Heart Disease Risk Factors

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. Identifier: NCT00065793
Recruitment Status : Completed
First Posted : August 4, 2003
Last Update Posted : February 3, 2015
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Frank M. Sacks, Brigham and Women's Hospital

Brief Summary:
To evaluate very low density lipoprotein (VLDL) and low density lipoprotein (LDL) particle types as predictors of initial coronary events.

Condition or disease
Cardiovascular Diseases Heart Diseases Coronary Disease Myocardial Infarction Diabetes Mellitus Diabetes Mellitus, Non-insulin Dependent

Detailed Description:


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.


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.

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Study Type : Observational
Actual Enrollment : 1478 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : July 2003
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Primary Outcome Measures :
  1. apoB concentration of LDL with apoC-III [ Time Frame: 10-14 years ]
    observational follow-up for coronary events

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Nurses Health Study Health Professionals Follow-up Study
Cases having first coronary event

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00065793

Sponsors and Collaborators
Brigham and Women's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Frank Sacks, MD Harvard School of Public Health
Principal Investigator: Frank Sacks, MD Brigham and Women's Hospital

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Responsible Party: Frank M. Sacks, Professor of Medicine, Brigham and Women's Hospital Identifier: NCT00065793     History of Changes
Other Study ID Numbers: 1232
R01HL070159 ( U.S. NIH Grant/Contract )
First Posted: August 4, 2003    Key Record Dates
Last Update Posted: February 3, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
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Heart Diseases
Myocardial Infarction
Coronary Disease
Coronary Artery Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Arterial Occlusive Diseases