Stroke Incidence and Risk Factors in a Tri-ethnic Region (NOMAS)
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|ClinicalTrials.gov Identifier: NCT03266952|
Recruitment Status : Completed
First Posted : August 30, 2017
Last Update Posted : August 31, 2017
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.
|Condition or disease|
|Diabetes Diet Epidemiology Stroke Myocardial Infarction|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||3497 participants|
|Official Title:||Stroke Incidence and Risk Factors in a Tri-ethnic Region|
|Actual Study Start Date :||January 1993|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
- Incidence of Stroke [ Time Frame: 24 years ]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"
- Incidence of myocardial infarction [ Time Frame: 24 years ]Myocardial Infarction is defined using the clinical, ECG and cardiac enzyme criteria adapted from the Cardiac Arrhythmia Suppression Trial and the Lipid Research Clinics Coronary Primary Prevention Trial and requires at least 2 of the 3 following criteria: (a) ischemic cardiac pain; (b) cardiac enzyme abnormalities; and (c) ECG abnormalities.
- Incidence of vascular death [ Time Frame: 24 years ]Death is classified as either being of vascular nature if due to stroke, myocardial infarction, heart failure, pulmonary embolus, or cardiac arrhythmia to the extent that this can be determined from available records and sources
- Scoring cognitive impairment [ Time Frame: Mean of 6 years after baseline ]A neuropsychological battery was administered and participants were scored on 4 cognitive domains: semantic memory, episodic memory, executive function, processing speed
- Incidence of diabetes [ Time Frame: 24 years ]Self-reported incidence of diabetes
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03266952
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Ralph L Sacco, MD||University of Miami|