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AtherosclerosisNCT00014833

Life Course Socioeconomic Status, Social Context and Cardiovascular Disease

An observational study of Atherosclerosis and Coronary Disease, run by University of North Carolina, Chapel Hill.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To investigate the inverse association between socioeconomic status (SES) and cardiovascular disease (CVD) in the Atherosclerosis Risk in Communities (ARIC) Study cohort. Read more about this study

Who is it for?
Ages Up to 100 years
How many people
15,872 participants
Where
No sites listed yet
Study dates
Mar 2001to Feb 2006
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 Up to 100 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

No eligibility criteria

About this study

To investigate the inverse association between socioeconomic status (SES) and cardiovascular disease (CVD) in the Atherosclerosis Risk in Communities (ARIC) Study cohort.

Read the detailed description

BACKGROUND:

It is well known that cardiovascular disease is inversely associated with SES. However, SES may change over time and for socially mobile individuals it is not clear whether the association with cardiovascular disease (CVD) differs for early life SES vs. mid-life SES. Another issue is that an individual may have a relatively high income and/or wealth, but may live in a low SES neighborhood. It would be desirable to separate out the effects of individual level vs. aggregate level SES. Finally, there is limited evidence that the association of SES with CVD may vary according to ethnic group. The bi-ethnic character of the ARIC population makes it a fertile environment to test this hypothesis.

DESIGN NARRATIVE:

Mechanisms will be identified which explain the strong inverse association between socioeconomic status (SES) over the life course and cardiovascular disease morbidity and mortality in the Atherosclerosis Risk in Communities (ARIC) , a bi-ethnic population-based sample of four U.S. communities. Health outcomes will include non-invasively measured subclinical cardiovascular disease, as well as fatal and non-fatal clinical disease manifestations ascertained over the course of 10 years of follow-up. Earlier life course socioeconomic status and measurements of current socioeconomic status and biomedical cardiovascular risk factors will be integrated with geocoded contemporary social environmental exposures to assess their impact on cardiovascular function, metabolic impairments, allostatic load, and subclinical and clinical disease. Multilevel analyses will be performed with the goal of identifying pathways by which socioeconomic status is related to cardiovascular disease, considering relevant health behavior, life styles, psychosocial stressors/support mechanisms, chronic infection/chronic inflammatory burden, autonomic nervous system dysfunction, and sustained metabolic impairments. The potential modification of the above associations by the social environment will be addressed by these analyses, as well as putative differences by gender and ethnicity.

These staged analytic goals are made possible by linking Census-based indicators of the social environment to the rich data resources of the ARIC Study, a bi-ethnic, community-based sample of men and women aged 45-64 years at the time of their baseline examination in 1987-1989. This cohort was re-examined every three years through January, 1999 with ascertainment of SES during childhood, early adulthood and in mid-life, health-relevant behaviors, numerous measurements of risk factors, and measures of subclinical cardiovascular disease such as carotid artery wall thickness, arterial distensibility, retinopathy, and lower extremity arterial disease. These data, as well as validated information on hospital discharge diagnoses and on cause-specific mortality accrued over 10 years of follow-up are available. Additional life course information on the members of the ARIC cohort will be collected during Year 1 of the study.

Being tested
No intervention
Medical subject headings
Atherosclerosis, Coronary Disease, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    No intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2001 (estimated)
  2. Study startMar 2001
  3. Primary completionFeb 2006
  4. Study completionFeb 2006

Resources

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
Retrospective
Enrolment
15,872 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00014833
Sponsor's protocol ID
965
Other IDs
R01HL064142
Status last verified
Apr 2016
First submitted
11 Apr 2001
Last updated
12 Apr 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Data shared through LOINCC and directly by request to the PI

Publications

  • Borrell LN, Diez Roux AV, Rose K, Catellier D, Clark BL; Atherosclerosis Risk in Communities Study. Neighbourhood characteristics and mortality in the Atherosclerosis Risk in Communities Study. Int J Epidemiol. 2004 Apr;33(2):398-407. doi: 10.1093/ije/dyh063.

    PubMed 15082648

Questions about this trial

What is this clinical trial studying?

An observational study of Atherosclerosis and Coronary Disease, run by University of North Carolina, Chapel Hill.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 12 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

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 NCT00014833, which also lists 1 linked publication.

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 12 Apr 2016.

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