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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
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    March 15, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    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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