AtherosclerosisNCT00344903
Dallas Heart Study 2: Return Clinic Visit for the Dallas Heart Study Cohort
An observational study of Atherosclerosis and Congestive Heart Failure, run by University of Texas Southwestern Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Congestive Heart Failure, Left Ventricular Hypertrophy
- How many people
- 3,400 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults who participated in DHS-1. The study will include equal numbers of men and women and will include 50% African Americans
Who may be able to join
- Age 35-70
- Participant in DHS-1 study completing visit 2 (blood sampling) and visit 3 (clinic visit)
- Provision of informed consent
Who cannot join
- None--population study
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center
Dallas, Texas, 75390-9047
About this study
Official title: 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:
- from health to ASHD risk;
- from ASHD risk to subclinical ASHD; and
- 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.
Read the 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:
- from health to ASHD risk;
- from ASHD risk to subclinical ASHD; and
- 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.
- Conditions
- Atherosclerosis, Congestive Heart Failure, Left Ventricular Hypertrophy, Diabetes Mellitus, Hypertension, Obesity
- Keywords
- Atherosclerosis, Heart Failure, Ventricular Hypertrophy, Myocardial Infarction, Screening, Hypertension, Diabetes, Obesity, Metabolic Syndrome
- Medical subject headings
- Atherosclerosis, Heart Failure, Hypertrophy, Left Ventricular, Diabetes Mellitus, Hypertension, Obesity, Metabolic Syndrome, Myocardial Infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2006 (estimated)
- Study startSep 2007
- Primary completionSep 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Donald W. Reynolds Foundation
- Investigators
- Helen Hobbs, MD, Study chair, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344903
- Sponsor's protocol ID
- DHS-2-001
- Status last verified
- Feb 2009
- First submitted
- 23 Jun 2006
- Last updated
- 8 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15194016Kay 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.
PubMed 32066275Rader 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.
PubMed 31522619Garg 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.
PubMed 28775115Cusano 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.
PubMed 23690312
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Cohort Study of Dallas County Residents to Identify Novel Determinants of Atherosclerotic Heart Disease: The DHS 2
- ClinicalTrials.gov ID
- NCT00344903
- Acronym / sponsor ID
- DHS-2-001
- Conditions
- Atherosclerosis, Congestive Heart Failure, Left Ventricular Hypertrophy, Diabetes Mellitus, Hypertension, Obesity
- Keywords
- Atherosclerosis, Heart Failure, Ventricular Hypertrophy, Myocardial Infarction, Screening, Hypertension, Diabetes, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,400 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Donald W. Reynolds Foundation
- Study start
- Sep 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 27 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- from health to ASHD risk;
- from ASHD risk to subclinical ASHD; and
- 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:
- from health to ASHD risk;
- from ASHD risk to subclinical ASHD; and
- 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
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who participated in DHS-1. The study will include equal numbers of men and women and will include 50% African Americans
Key inclusion criteria (3 listed)
- Age 35-70
- Participant in DHS-1 study completing visit 2 (blood sampling) and visit 3 (clinic visit)
- Provision of informed consent
Key exclusion criteria (1 listed)
- None--population study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2010.
- Background: PubMed 15194016Victor 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.
- Derived from this study: PubMed 32066275Kay 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.
- Derived from this study: PubMed 31522619Rader 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.
- Derived from this study: PubMed 28775115Garg 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.
- Derived from this study: PubMed 23690312Cusano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Hobbs, MD study chair
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Congestive Heart Failure, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00344903, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2010.