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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00344903
Other study ID # DHS-2-001
Secondary ID
Status Completed
Phase N/A
First received June 23, 2006
Last updated July 7, 2010
Start date September 2007
Est. completion date December 2009

Study information

Verified date February 2009
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 3400
Est. completion date December 2009
Est. primary completion date September 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 35 Years to 70 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
United States UT Southwestern Medical Center Dallas Texas

Sponsors (2)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center Donald W. Reynolds Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Victor RG, Haley RW, Willett DL, Peshock RM, Vaeth PC, Leonard D, Basit M, Cooper RS, Iannacchione VG, Visscher WA, Staab JM, Hobbs HH; Dallas Heart Study Investigators. The Dallas Heart Study: a population-based probability sample for the multidisciplinary study of ethnic differences in cardiovascular health. Am J Cardiol. 2004 Jun 15;93(12):1473-80. — View Citation

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