Clinical trial NCT00344903: Dallas Heart Study 2: Return Clinic Visit for the Dallas Heart Study Cohort
Official title: Longitudinal Cohort Study of Dallas County Residents to Identify Novel Determinants of Atherosclerotic Heart Disease: The DHS 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Congestive Heart Failure
Left Ventricular Hypertrophy
Diabetes Mellitus
Hypertension
Obesity
Metabolic Syndrome X
Myocardial Infarction
Keywords: Atherosclerosis
Heart Failure
Ventricular Hypertrophy
Myocardial Infarction
Screening
Hypertension
Diabetes
Obesity
Metabolic Syndrome
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Donald W. Reynolds Foundation
First posted: 2006-06-27
Enrollment: 3400
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Helen Hobbs, MD
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1016/j.amjcard.2004.02.058.
citation: Kay FU, Abbara S, Joshi PH, Garg S, Khera A, Peshock RM. Identification of High-Risk Left Ventricular Hypertrophy on Calcium Scoring Cardiac Computed Tomography Scans: Validation in the DHS. Circ Cardiovasc Imaging. 2020 Feb;13(2):e009678. doi: 10.1161/CIRCIMAGING.119.009678. Epub 2020 Feb 18.
citation: Rader F, Franklin SS, Mirocha J, Vongpatanasin W, Haley RW, Victor RG. Superiority of Out-of-Office Blood Pressure for Predicting Hypertensive Heart Disease in Non-Hispanic Black Adults. Hypertension. 2019 Nov;74(5):1192-1199. doi: 10.1161/HYPERTENSIONAHA.119.13542. Epub 2019 Sep 16.
citation: Garg S, de Lemos JA, Matulevicius SA, Ayers C, Pandey A, Neeland IJ, Berry JD, McColl R, Maroules C, Peshock RM, Drazner MH. Association of Concentric Left Ventricular Hypertrophy With Subsequent Change in Left Ventricular End-Diastolic Volume: The Dallas Heart Study. Circ Heart Fail. 2017 Aug;10(8):e003959. doi: 10.1161/CIRCHEARTFAILURE.117.003959.
citation: Cusano NE, Maalouf NM, Wang PY, Zhang C, Cremers SC, Haney EM, Bauer DC, Orwoll ES, Bilezikian JP. Normocalcemic hyperparathyroidism and hypoparathyroidism in two community-based nonreferral populations. J Clin Endocrinol Metab. 2013 Jul;98(7):2734-41. doi: 10.1210/jc.2013-1300. Epub 2013 May 20.