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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
  Purpose

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.


Condition
Atherosclerosis
Congestive Heart Failure
Left Ventricular Hypertrophy
Diabetes Mellitus
Hypertension
Obesity
Metabolic Syndrome X
Myocardial Infarction

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Biospecimen Retention:   Samples With DNA

Plasma Serum DNA


Enrollment: 3400
Study Start Date: September 2007
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344903

Locations
United States, Texas
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Helen Hobbs, MD, UT Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00344903     History of Changes
Other Study ID Numbers: DHS-2-001
Study First Received: June 23, 2006
Last Updated: July 7, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Atherosclerosis
Heart Failure
Ventricular Hypertrophy
Myocardial Infarction
Screening
Hypertension
Diabetes
Obesity
Metabolic Syndrome

Additional relevant MeSH terms:
Hypertension
Diabetes Mellitus
Obesity
Heart Failure
Infarction
Syndrome
Myocardial Infarction
Metabolic Syndrome X
Atherosclerosis
Arteriosclerosis
Hypertrophy
Hypertrophy, Left Ventricular
Coronary Artery Disease
Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Heart Diseases
Ischemia
Pathologic Processes
Necrosis
Disease
Insulin Resistance

ClinicalTrials.gov processed this record on September 18, 2014