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Stroke Incidence and Risk Factors in a Tri-ethnic Region

NCT03266952 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3497

Last updated 2023-01-12

No results posted yet for this study

Summary

Enrollment of a population-based, prospective cohort of 3298 stroke-free adults was completed in 2001 and annual follow-up has continued since then. This collaborative study is the first prospective cohort study among whites, blacks and Caribbean Hispanics living in the same community. This grant supports continued follow-up and outcome detection and expansion of data collection in this cohort. The aims are to evaluate the relationship between vascular outcomes (stroke, myocardial infarction (MI), and vascular death) and insulin resistance, carotid intima-media thickness, carotid distensibility, and quantitative magnetic resonance imaging (MRI) measures of vascular subclinical brain disease and to determine if MRI subclinical disease accounts for race/ethnic differences in cognitive impairment. To accomplish these aims further data collection using the population-based, prospective cohort study is proposed. Stored baseline serum will be used to measure fasting insulin levels to evaluate insulin resistance. High-resolution carotid imaging data will be collected at subsequent visits to expand the measurements of subclinical carotid disease to 1300 subjects. MRIs and a neuropsychological battery emphasizing frontal executive domains will be done on 1300 subjects and quantitative analyses performed to measure white matter hyperintensities, silent infarcts, and silent cerebral microbleeds.

Starting in 2005, subjects enrolled in the MRI substudy began to have echocardiograms and 24hour ambulatory blood pressure monitoring. Subjects will be followed by annual telephone interviews to ascertain stroke, MI, death, and changes in cognitive state. In-person assessment will be done for all subjects who screen positive. Community stroke surveillance will be maintained to insure stroke detection among the cohort. Specific diagnostic committees classify stroke, MI and vascular death.

Conditions

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Columbia University

    collaborator OTHER

  • University of Miami

    lead OTHER

Principal Investigators

  • Ralph L Sacco, MD · University of Miami

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1993-01-31
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03266952 on ClinicalTrials.gov