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NCT03266952 · ClinicalTrials.gov registry record
Stroke Incidence and Risk Factors in a Tri-ethnic Region
A clinical trial, sponsored by University of Miami.
- Completed
- Registry status
- 3,497
- Enrollment target
NCT03266952: Completed study, sponsored by University of Miami.
NCT03266952 is a clinical trial that has completed, run by University of Miami. The registered enrollment target is 3,497 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03266952 has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- 3,497 participants
- Enrollment target
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.
Primary Outcome
Stroke is defined as first symptomatic stroke of any type, based on World Health Organization (WHO) criteria as "rapidly developing clinical signs of focal (at times global) disturbance of cerebral function, lasting more than 24 hours or leading to death with no apparent cause other than that of vascular origin"
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,497 participants |
| Start Date | 1993-01 |
| Est. Completion | 2022-12 |
What the finished NCT03266952 record still lists
NCT03266952 is an observational study that tracks outcomes without assigning an intervention. Its 3,497 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT03266952 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03266952 about?
NCT03266952 is a clinical study titled "Stroke Incidence and Risk Factors in a Tri-ethnic Region". 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 su...
What is the current status of trial NCT03266952?
This trial is currently completed. The enrollment target is 3,497 participants. The study started on 1993-01. Estimated completion is 2022-12.
Who is sponsoring clinical trial NCT03266952?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
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