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VLDL and LDL Particle Types as Coronary Heart Disease Risk Factors

This study has been completed.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00065793
  Purpose

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


Condition Phase
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Myocardial Infarction
Diabetes Mellitus
Diabetes Mellitus, Non-Insulin Dependent
N/A

MedlinePlus related topics:   Diabetes    Heart Attack    Heart Diseases   

U.S. FDA Resources

Study Type:   Observational

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date:   July 2003
Study Completion Date:   June 2008
Primary Completion Date:   June 2008 (Final data collection date for primary outcome measure)

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.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

No eligibility criteria

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065793

Sponsors and Collaborators

Investigators
Investigator:     Frank Sacks     Harvard School of Public Health    
  More Information


Study ID Numbers:   1232
First Received:   July 31, 2003
Last Updated:   July 1, 2008
ClinicalTrials.gov Identifier:   NCT00065793
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Heart Diseases
Metabolic Diseases
Myocardial Ischemia
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Ischemia
Coronary Disease
Necrosis
Diabetes Mellitus, Type 2
Endocrinopathy
Metabolic disorder
Infarction
Glucose Metabolism Disorders
Myocardial Infarction

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 17, 2008




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