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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
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Columbia University
Information provided by (Responsible Party):
Ralph L Sacco, MD MS, University of Miami

Brief 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.


Condition or disease
Diabetes Diet Epidemiology Stroke Myocardial Infarction

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 3497 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. 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"


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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


Other Outcome Measures:
  1. Incidence of diabetes [ Time Frame: 24 years ]
    Self-reported incidence of diabetes



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
NOMAS is a prospective population-based cohort study, recruited 1993-2001, with the original goal of identifying the incidence of and risk factors for stroke in a multi-ethnic urban adult population. Northern Manhattan is a well-defined region of New York City with a race/ethnic distribution of 63% Hispanics, 20% Non-Hispanic black, and 15% non-Hispanic white residents
Criteria

Inclusion Criteria:

  • Northern Manhattan Study participants were selected using random-digit dialing with the following eligibility criteria: never diagnosed with stroke; greater than 40 years old; resided in Northern Manhattan for at least 3 months, in a household with a telephone.

Exclusion Criteria:

  • For this analysis we excluded participants with diabetes mellitus at baseline, defined by the participant's self-reported diabetes, use of insulin or oral anti-diabetic medication, or fasting glucose at least 126 mg/dl. We also excluded participants missing data for soda consumption, and those with improbable total daily kilocalories based on food frequency responses.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03266952


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
National Institute of Neurological Disorders and Stroke (NINDS)
Columbia University
Investigators
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Principal Investigator: Ralph L Sacco, MD University of Miami

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Responsible Party: Ralph L Sacco, MD MS, Principal Investigator, University of Miami
ClinicalTrials.gov Identifier: NCT03266952     History of Changes
Other Study ID Numbers: 20070212
R37NS029993 ( U.S. NIH Grant/Contract )
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ralph L Sacco, MD MS, University of Miami:
stroke
race
diet
diabetes
ethnicity
myocardial infarction

Additional relevant MeSH terms:
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Stroke
Infarction
Myocardial Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases