Dallas Heart Study 2: Return Clinic Visit for the Dallas Heart Study Cohort

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00344903
Collaborator
Donald W. Reynolds Foundation (Other)
3,400
1
27
125.9

Study Details

Study Description

Brief Summary

The Dallas Heart Study (DHS-1) is a large, multi-ethnic, population-based epidemiological study designed to identify determinants of atherosclerotic heart disease (ASHD) in a representative United States (US) urban environment. This study completed enrollment in 2003.

Our objective is to pinpoint factors contributing to progression:
  1. from health to ASHD risk;

  2. from ASHD risk to subclinical ASHD; and

  3. from subclinical to clinical ASHD.

Identification of the critical factors in these transitions will enable targeted implementation of appropriate therapy to interdict before clinical ASHD develops.

Detailed Description

Early medical intervention in asymptomatic individuals at risk is the most effective strategy to combat atherosclerotic heart disease (ASHD). The major roadblock to effective ASHD prevention is that conventional tools to assess ASHD risk are inadequate and new methods are needed to identify susceptible individuals before the disease process is established. Other successful public-health screening programs have incorporated direct imaging procedures (e.g. mammography, colonoscopy); yet in ASHD, direct imaging of the vasculature has not been incorporated into the risk stratification algorithms.

The Dallas Heart Study (DHS-1) is a large, multi-ethnic, population-based epidemiological study designed to identify determinants of ASHD in a representative US urban environment. This study completed enrollment in 2003.

In DHS-2 we will transform the Dallas Heart Study from a cross-sectional health survey (DHS-1) into a longitudinal cohort study (DHS-2). We will perform state-of-the-art cardiovascular (CV) imaging coupled to biomarkers, genetic markers and classical ASHD risk factors. We will repeat the detailed clinical phenotyping performed between 2000-2003 to capture interval changes in ASHD risk and disease burden. Our objective is to pinpoint factors contributing to progression:

  1. from health to ASHD risk;

  2. from ASHD risk to subclinical ASHD; and

  3. from subclinical to clinical ASHD.

Identification of the critical factors in these transitions will enable targeted implementation of appropriate therapy to interdict before clinical ASHD develops.

Study Design

Study Type:
Observational
Actual Enrollment :
3400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Longitudinal Cohort Study of Dallas County Residents to Identify Novel Determinants of Atherosclerotic Heart Disease: The DHS 2
Study Start Date :
Sep 1, 2007
Actual Primary Completion Date :
Sep 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Age 35-70

    • Participant in DHS-1 study completing visit 2 (blood sampling) and visit 3 (clinic visit)

    • Provision of informed consent

    Exclusion Criteria:
    • None--population study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UT Southwestern Medical Center Dallas Texas United States 75390-9047

    Sponsors and Collaborators

    • University of Texas Southwestern Medical Center
    • Donald W. Reynolds Foundation

    Investigators

    • Study Chair: Helen Hobbs, MD, UT Southwestern Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00344903
    Other Study ID Numbers:
    • DHS-2-001
    First Posted:
    Jun 27, 2006
    Last Update Posted:
    Jul 8, 2010
    Last Verified:
    Feb 1, 2009

    Study Results

    No Results Posted as of Jul 8, 2010