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

This study has been completed.
Sponsor:
Collaborator:
Donald W. Reynolds Foundation
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00344903
First received: June 23, 2006
Last updated: July 7, 2010
Last verified: February 2009

June 23, 2006
July 7, 2010
September 2007
September 2009   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00344903 on ClinicalTrials.gov Archive Site
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Dallas Heart Study 2: Return Clinic Visit for the Dallas Heart Study Cohort
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Plasma Serum DNA

Probability Sample

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

  • Atherosclerosis
  • Congestive Heart Failure
  • Left Ventricular Hypertrophy
  • Diabetes Mellitus
  • Hypertension
  • Obesity
  • Metabolic Syndrome X
  • Myocardial Infarction
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3400
December 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
35 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00344903
DHS-2-001
Yes
Helen Hobbs, MD, UT Southwestern Medical Center
University of Texas Southwestern Medical Center
Donald W. Reynolds Foundation
Study Chair: Helen Hobbs, MD UT Southwestern Medical Center
University of Texas Southwestern Medical Center
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP