Cardiovascular DiseasesNCT00063557
Neighborhoods and CVD Risk in a Multiethnic Cohort - Ancillary to MESA
An observational study of Cardiovascular Diseases and Coronary Disease, run by University of Michigan.
Trial summary
To investigate if neighborhood characteristics are related to disease risk in a multiethnic cohort. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jun 2003to Apr 2007
- 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 if neighborhood characteristics are related to disease risk in a multiethnic cohort.
Read the detailed description
BACKGROUND:
Recent epidemiologic studies have found that living in socioeconomically disadvantaged neighborhoods is associated with increased prevalence and incidence of coronary heart disease, even after controlling for measures of personal income, education, and occupation. Although this suggests that features of neighborhoods may be relevant to cardiovascular risk, important questions remain regarding whether the associations observed reflect causal processes. Two important unresolved issues are the role of selection factors in generating these associations and the need to identify the specific characteristics of neighborhoods that are relevant.
DESIGN NARRATIVE:
The study uses publicly available and newly collected neighborhood data linked to the Multi-Ethnic Study of Atherosclerosis (MESA) to: (1) examine the relationship between neighborhood socioeconomic characteristics and the prevalence and progression of subclinical atherosclerosis; (2) examine associations of neighborhood socioeconomic characteristics with specific individual-level factors which may mediate neighborhood differences in disease risk; (3) develop measures of specific characteristics of neighborhood environments (such as measures of resource availability, neighborhood social cohesion and neighborhood stress) and examine their relation to selected individual-level risk factors; (4) determine if these specific neighborhood characteristics explain differences in cardiovascular risk between socioeconomically advantaged and socioeconomically disadvantaged neighborhoods; and (5) examine if neighborhood characteristics contribute to race/ethnic differences in cardiovascular risk. Measures of neighborhood attributes will be based on Year 2000 Census data, surveys of area residents, and the use of GIS methods to link data on area resources to MESA neighborhoods. The examination of subclinical disease as outcomes avoids problems related to selection of persons into neighborhoods based on their health status. The project will use two innovative approaches (residential surveys and ecometric techniques and GIS-based methods) to develop direct measures of specific neighborhood attributes in order to test their relationship to disease risk. Confirming that specific features of neighborhoods are causally related to disease would have important implications for prevention.
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Atherosclerosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2003 (estimated)
- Study startJun 2003
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Ana Diez-Roux, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00063557
- Sponsor's protocol ID
- 1220
- Other IDs
- R01HL071759
- Status last verified
- Jan 2008
- First submitted
- 30 Jun 2003
- Last updated
- 11 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neighborhoods and CVD Risk in a Multiethnic Cohort - Ancillary to MESA
- ClinicalTrials.gov ID
- NCT00063557
- Acronym / sponsor ID
- 1220
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2003
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 1 Jul 2003 (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 if neighborhood characteristics are related to disease risk in a multiethnic cohort.
Detailed description
BACKGROUND:
Recent epidemiologic studies have found that living in socioeconomically disadvantaged neighborhoods is associated with increased prevalence and incidence of coronary heart disease, even after controlling for measures of personal income, education, and occupation. Although this suggests that features of neighborhoods may be relevant to cardiovascular risk, important questions remain regarding whether the associations observed reflect causal processes. Two important unresolved issues are the role of selection factors in generating these associations and the need to identify the specific characteristics of neighborhoods that are relevant.
DESIGN NARRATIVE:
The study uses publicly available and newly collected neighborhood data linked to the Multi-Ethnic Study of Atherosclerosis (MESA) to: (1) examine the relationship between neighborhood socioeconomic characteristics and the prevalence and progression of subclinical atherosclerosis; (2) examine associations of neighborhood socioeconomic characteristics with specific individual-level factors which may mediate neighborhood differences in disease risk; (3) develop measures of specific characteristics of neighborhood environments (such as measures of resource availability, neighborhood social cohesion and neighborhood stress) and examine their relation to selected individual-level risk factors; (4) determine if these specific neighborhood characteristics explain differences in cardiovascular risk between socioeconomically advantaged and socioeconomically disadvantaged neighborhoods; and (5) examine if neighborhood characteristics contribute to race/ethnic differences in cardiovascular risk. Measures of neighborhood attributes will be based on Year 2000 Census data, surveys of area residents, and the use of GIS methods to link data on area resources to MESA neighborhoods. The examination of subclinical disease as outcomes avoids problems related to selection of persons into neighborhoods based on their health status. The project will use two innovative approaches (residential surveys and ecometric techniques and GIS-based methods) to develop direct measures of specific neighborhood attributes in order to test their relationship to disease risk. Confirming that specific features of neighborhoods are causally related to disease would have important implications for prevention.
Study design
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.
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 11 Apr 2016.
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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.
Ana Diez-Roux
University of Michigan
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Coronary Disease, run by University of Michigan.
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 11 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?
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 11 Apr 2016.