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| Tracking Information | |||||
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| First Received Date ICMJE | June 30, 2003 | ||||
| Last Updated Date | January 24, 2008 | ||||
| Start Date ICMJE | June 2003 | ||||
| Primary Completion Date | April 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00063557 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Neighborhoods and CVD Risk in a Multiethnic Cohort - Ancillary to MESA | ||||
| Official Title ICMJE | |||||
| Brief Summary | To investigate if neighborhood characteristics are related to disease risk in a multiethnic cohort. |
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| 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. |
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| Study Phase | N/A | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | |||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | April 2007 | ||||
| Primary Completion Date | April 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | No eligibility criteria |
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00063557 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 1220 | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | January 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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