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.
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
- Conditions the study is for
- Atherosclerosis, Coronary Disease, Cardiovascular Diseases
- 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.
- Conditions
- Atherosclerosis, Coronary Disease, Cardiovascular Diseases
- 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.
- First posted12 Apr 2001 (estimated)
- Study startMar 2001
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 North Carolina, Chapel HillThe 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
- Retrospective
- Enrolment
- 15,872 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Gerardo Heiss, University of North Carolina, Chapel Hill
- Investigators
- Gerardo Heiss, University of North Carolina
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life Course Socioeconomic Status, Social Context and Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT00014833
- Acronym / sponsor ID
- 965
- Conditions
- Atherosclerosis, Coronary Disease, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,872 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2001
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 12 Apr 2001 (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.
To investigate the inverse association between socioeconomic status (SES) and cardiovascular disease (CVD) in the Atherosclerosis Risk in Communities (ARIC) Study cohort.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
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 12 Apr 2016.
- Background: PubMed 15082648Borrell 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.
- Individual participant dataSharing planned: Yes. Data shared through LOINCC and directly by request to the PI
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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.
Gerardo Heiss
University of North Carolina
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.