Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • apoB concentration of LDL with apoC-III [ Time Frame: 10-14 years ] [ Designated as safety issue: No ]
    observational follow-up for coronary events


Enrollment: 1478
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:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Nurses Health Study Health Professionals Follow-up Study

Criteria

Cases having first coronary event

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Frank Sacks, MD Harvard School of Public Health
Principal Investigator: Frank Sacks, MD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Frank M. Sacks, Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00065793     History of Changes
Other Study ID Numbers: 1232, R01HL070159
Study First Received: July 31, 2003
Last Updated: January 29, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on November 25, 2014