Re-evaluating Triglycerides in Coronary Heart Disease
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Coronary Disease
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005442
First Posted
May 25, 2000
Last Updated
March 15, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005442
Brief Title
Re-evaluating Triglycerides in Coronary Heart Disease
Study Type
Observational
2. Study Status
Record Verification Date
March 2005
Overall Recruitment Status
Completed
Study Start Date
June 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2000 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To conduct a comprehensive epidemiologic investigation into the relationship between serum triglyceride (TG) levels and coronary heart disease (CHD).
Detailed Description
BACKGROUND:
The results of this investigation helped to shed substantial light on the controversial relationship between triglycerides and coronary heart disease, a topic of great importance to preventive cardiology. Additionally, important methodological information was obtained in the study of interactions and precision of variables in epidemiologic analysis.
DESIGN NARRATIVE:
There were three components to the study: 1) an analysis of several existing cardiovascular databases for evidence of a significant association between coronary heart disease and specific lipid interactions involving triglycerides; 2) an analysis of these databases to investigate the role of measurement precision on the association between elevated triglyceride levels and coronary heart disease; and 3) a survey of both expert lipidologists and community clinicians to examine current practices related to screening for and treatment of elevated triglyceride levels for the purpose of reducing coronary heart disease risk. Five databases were used in the first two components of this study. These data sets included those of the Lipid Research Clinics Prevalence and Mortality Follow-up Studies; the Lipid Research Clinics Coronary Primary Prevention Trial; the Multiple Risk Factor Intervention Trial; the National Heart, Lung, and Blood Type II Coronary Intervention Study; and the Coronary Drug Project. For the first component, detailed statistical analyses of all databases were performed, specifically examining the role of lipid interactions involving triglycerides and their association with coronary heart disease. For the second component, more precise estimates of each subject's lipid levels were recalculated using the multiple lipid measurements already available in each database. Each dataset was then analyzed for evidence of an independent relationship between triglycerides and coronary heart disease and to validate the theoretical findings suggesting that measurement imprecision may explain the difficulty of detecting an independent triglyceride-coronary heart disease association. The public health implications of the current state of knowledge surrounding triglycerides were assessed with survey research techniques in the third component.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Coronary Disease, Hypertriglyceridemia
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Avins
Organizational Affiliation
University of California at San Francisco
12. IPD Sharing Statement
Citations:
PubMed Identifier
8779464
Citation
Avins AL, Browner WS. Lowering risk without lowering cholesterol: implications for national cholesterol policy. Ann Intern Med. 1996 Sep 15;125(6):502-6. doi: 10.7326/0003-4819-125-6-199609150-00012.
Results Reference
background
PubMed Identifier
9466637
Citation
Avins AL, Browner WS. Improving the prediction of coronary heart disease to aid in the management of high cholesterol levels: what a difference a decade makes. JAMA. 1998 Feb 11;279(6):445-9. doi: 10.1001/jama.279.6.445.
Results Reference
background
PubMed Identifier
10888968
Citation
Avins AL, Neuhaus JM. Do triglycerides provide meaningful information about heart disease risk? Arch Intern Med. 2000 Jul 10;160(13):1937-44. doi: 10.1001/archinte.160.13.1937.
Results Reference
background
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Re-evaluating Triglycerides in Coronary Heart Disease
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