VLDL and LDL Particle Types as Coronary Heart Disease Risk Factors

NCT ID: NCT00065793

Last Updated: 2015-02-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1478 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2008-06-30

Brief Summary

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

Detailed Description

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.

Conditions

Cardiovascular Diseases; Heart Diseases; Coronary Disease; Myocardial Infarction; Diabetes Mellitus; Diabetes Mellitus, Non-insulin Dependent

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

Cases having first coronary event

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Frank M. Sacks

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank Sacks, MD

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Frank Sacks, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Other Identifiers

R01HL070159

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1232

Identifier Type: -

Identifier Source: org_study_id