Obesity Clinical Trial - Dallas Heart Study 2: Return Clinic Visit for

Status Completed

Clinical Trial 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.

Clinical Trial 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00344903
Study type	Observational
Source	University of Texas Southwestern Medical Center
Contact
Status	Completed
Phase	N/A
Start date	September 2007
Completion date	December 2009

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms