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

July 7, 2010 updated by: University of Texas Southwestern Medical Center

Longitudinal Cohort Study of Dallas County Residents to Identify Novel Determinants of Atherosclerotic Heart Disease: The DHS 2

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

3400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390-9047
        • UT Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults who participated in DHS-1. The study will include equal numbers of men and women and will include 50% African Americans

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

Donald W. Reynolds Foundation

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

June 23, 2006

First Submitted That Met QC Criteria

June 23, 2006

First Posted (Estimate)

June 27, 2006

Study Record Updates

Last Update Posted (Estimate)

July 8, 2010

Last Update Submitted That Met QC Criteria

July 7, 2010

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DHS-2-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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