<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03266952</url>
  </required_header>
  <id_info>
    <org_study_id>20070212</org_study_id>
    <secondary_id>R37NS029993</secondary_id>
    <nct_id>NCT03266952</nct_id>
  </id_info>
  <brief_title>Stroke Incidence and Risk Factors in a Tri-ethnic Region</brief_title>
  <acronym>NOMAS</acronym>
  <official_title>Stroke Incidence and Risk Factors in a Tri-ethnic Region</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Enrollment of a population-based, prospective cohort of 3298 stroke-free adults was completed&#xD;
      in 2001 and annual follow-up has continued since then. This collaborative study is the first&#xD;
      prospective cohort study among whites, blacks and Caribbean Hispanics living in the same&#xD;
      community. This grant supports continued follow-up and outcome detection and expansion of&#xD;
      data collection in this cohort. The aims are to evaluate the relationship between vascular&#xD;
      outcomes (stroke, myocardial infarction (MI), and vascular death) and insulin resistance,&#xD;
      carotid intima-media thickness, carotid distensibility, and quantitative magnetic resonance&#xD;
      imaging (MRI) measures of vascular subclinical brain disease and to determine if MRI&#xD;
      subclinical disease accounts for race/ethnic differences in cognitive impairment. To&#xD;
      accomplish these aims further data collection using the population-based, prospective cohort&#xD;
      study is proposed. Stored baseline serum will be used to measure fasting insulin levels to&#xD;
      evaluate insulin resistance. High-resolution carotid imaging data will be collected at&#xD;
      subsequent visits to expand the measurements of subclinical carotid disease to 1300 subjects.&#xD;
      MRIs and a neuropsychological battery emphasizing frontal executive domains will be done on&#xD;
      1300 subjects and quantitative analyses performed to measure white matter hyperintensities,&#xD;
      silent infarcts, and silent cerebral microbleeds.&#xD;
&#xD;
      Starting in 2005, subjects enrolled in the MRI substudy began to have echocardiograms and&#xD;
      24hour ambulatory blood pressure monitoring. Subjects will be followed by annual telephone&#xD;
      interviews to ascertain stroke, MI, death, and changes in cognitive state. In-person&#xD;
      assessment will be done for all subjects who screen positive. Community stroke surveillance&#xD;
      will be maintained to insure stroke detection among the cohort. Specific diagnostic&#xD;
      committees classify stroke, MI and vascular death.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke remains a major public health problem with a disproportionate impact on blacks and&#xD;
      Hispanics.&#xD;
&#xD;
      Studies in Northern Manhattan have demonstrated that blacks and Hispanics have a greater&#xD;
      stroke incidence and more frequently have small vessel and intracranial atherosclerotic&#xD;
      stroke than whites.&#xD;
&#xD;
      The reasons for these race/ethnic disparities are not entirely clear. Enrollment of a&#xD;
      population-based, prospective cohort of 3298 stroke-free adults was completed in 2001 and&#xD;
      annual followup has continued since then. This collaborative study is the first prospective&#xD;
      cohort study among whites, blacks and Caribbean Hispanics living in the same community. This&#xD;
      grant supports continued followup and outcome detection and expansion of data collection in&#xD;
      this cohort. The aims are to evaluate the relationship between vascular outcomes (stroke, MI,&#xD;
      and vascular death) and insulin resistance, carotid intima-media thickness, carotid&#xD;
      distensibility, and quantitative MRI measures of vascular subclinical brain disease and to&#xD;
      determine if MRI subclinical disease accounts for race/ethnic differences in cognitive&#xD;
      impairment. To accomplish these aims further data collection using the population-based,&#xD;
      prospective cohort study is proposed. Stored baseline serum will be used to measure fasting&#xD;
      insulin levels to evaluate insulin resistance. High resolution carotid imaging data will be&#xD;
      collected at subsequent visits to expand the measurements of subclinical carotid disease to&#xD;
      1300 subjects. MRIs and a neuropsychological battery emphasizing frontal executive domains&#xD;
      will be done on 1300 subjects and quantitative analyses performed to measure white matter&#xD;
      hyperintensities, silent infarcts, and silent cerebral microbleeds.&#xD;
&#xD;
      Starting in 2005, subjects enrolled in the MRI substudy began to have echocardiograms and&#xD;
      24hour ambulatory blood pressure monitoring. Subjects will be followed by annual telephone&#xD;
      interviews to ascertain stroke, MI, death, and changes in cognitive state. In-person&#xD;
      assessment will be done for all subjects who screen positive. Community stroke surveillance&#xD;
      will be maintained to insure stroke detection among the cohort. Specific diagnostic&#xD;
      committees classify stroke, MI and vascular death. The strengths of this cohort study are the&#xD;
      wealth of baseline data already assembled, the triethnic composition residing in the same&#xD;
      community, the outstanding followup record, the evaluation of putative risk factors, and the&#xD;
      innovative assessment of MRI subclinical disease and carotid subclinical disease. The study&#xD;
      primary hypotheses are:1. To determine the independent association of insulin resistance&#xD;
      among nondiabetics and the incidence of stroke, as well as stroke, MI or vascular death,&#xD;
      after adjusting for known modifiable risk factors such as hypertension, lipids, cigarettes,&#xD;
      and alcohol. 2.&#xD;
&#xD;
      To evaluate the independent association of subclinical carotid disease (carotid intima-media&#xD;
      thickness and carotid distensibility) and the incidence of stroke, MI or vascular death after&#xD;
      adjusting for conventional modifiable vascular risk factors, as well as novel vascular risk&#xD;
      factors such as homocysteine, high density lipoprotein (HDL) subpopulations, and insulin&#xD;
      resistance.3. To compare the prevalence of subclinical vascular brain disease as measured by&#xD;
      quantitative MRI, including white matter hyperintensities, silent infarcts, and silent&#xD;
      cerebral microbleeds, in each race/ethnic subgroup and determine the association between&#xD;
      subclinical brain disease and modifiable vascular risk factors measured up to 10 years prior&#xD;
      to MRI. Vascular risk factors will include baseline and repeated measures of conventional&#xD;
      modifiable conditions such as hypertension, diabetes, lipid levels, cigarette smoking,&#xD;
      physical activity, alcohol use, as well as less-well documented factors such as homocysteine,&#xD;
      HDL subpopulations, and insulin resistance. 4. To determine the relationship between&#xD;
      subclinical vascular brain diseases and cognitive impairment, particularly diminished&#xD;
      performance in frontal executive tests, and whether these MRI findings help explain cognitive&#xD;
      performance differences among whites, blacks and Hispanics after adjusting for age and&#xD;
      education.5. To explore whether subclinical vascular brain diseases are important predictors&#xD;
      of stroke, MI or vascular death. Beginning in Summer 2005, some new aims were added as&#xD;
      follows: 1) to determine whether aortic arch abnormalities and/or cardiac abnormalities,&#xD;
      and/or 24hour blood pressure levels and changes, are independently associated with silent&#xD;
      brain infarcts in the elderly; 2) to determine the risk of symptomatic stroke, myocardial&#xD;
      infarction and vascular death associated with aortic/cardiac/24hour blood pressure&#xD;
      abnormalities. As of 2010 the investigators will be collaborating with other institutions&#xD;
      under the NINDS Ischemic Stroke Genetics (ISG) study. The aims of the NINDS Ischemic Stroke&#xD;
      Genetics Study (NINDS ISG Study; NIH Grant 1 U01 NS06920801) are to:1) Assemble ischemic&#xD;
      stroke phenotypic data and high quality DNA data from 10 stroke studies. (Participating&#xD;
      studies in the NINDS ISG Study: Ischemic Stroke Genetics Study; Siblings with Ischemic Stroke&#xD;
      Study; Greater Cincinnati/Northern Kentucky Stroke Study; Genes Affecting Stroke Risk and&#xD;
      Outcome Study/Bugher Network Study; Northern Manhattan Study; Baltimore/Washington Young&#xD;
      Stroke Study; Heart and Vascular Health Stroke Study; Nurses Health Study; Reasons for&#xD;
      Geographic and Racial Differences in Stroke; Women's Health Initiative). This collaboration&#xD;
      has access to 7,033 cases of ischemic stroke and 23,411 study-specific controls. 2) Test for&#xD;
      associations with ischemic stroke and its subtypes in the NINDS ISG Study. 3) Replicate and&#xD;
      extend associations detected in Aim 1.2 above by taking advantage of other genomewide&#xD;
      association studies conducted by other members of the Ischemic Stroke Genetics studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1993</start_date>
  <completion_date type="Actual">December 2022</completion_date>
  <primary_completion_date type="Actual">December 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Stroke</measure>
    <time_frame>24 years</time_frame>
    <description>Stroke is defined as first symptomatic stroke of any type, based on World Health Organization (WHO) criteria as &quot;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&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of myocardial infarction</measure>
    <time_frame>24 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of vascular death</measure>
    <time_frame>24 years</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scoring cognitive impairment</measure>
    <time_frame>Mean of 6 years after baseline</time_frame>
    <description>A neuropsychological battery was administered and participants were scored on 4 cognitive domains: semantic memory, episodic memory, executive function, processing speed</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of diabetes</measure>
    <time_frame>24 years</time_frame>
    <description>Self-reported incidence of diabetes</description>
  </other_outcome>
  <enrollment type="Actual">3497</enrollment>
  <condition>Diabetes</condition>
  <condition>Diet</condition>
  <condition>Epidemiology</condition>
  <condition>Stroke</condition>
  <condition>Myocardial Infarction</condition>
  <eligibility>
    <study_pop>
      <textblock>
        NOMAS is a prospective population-based cohort study, recruited 1993-2001, with the&#xD;
        original goal of identifying the incidence of and risk factors for stroke in a multi-ethnic&#xD;
        urban adult population. Northern Manhattan is a well-defined region of New York City with a&#xD;
        race/ethnic distribution of 63% Hispanics, 20% Non-Hispanic black, and 15% non-Hispanic&#xD;
        white residents&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Northern Manhattan Study participants were selected using random-digit dialing with&#xD;
             the following eligibility criteria: never diagnosed with stroke; greater than 40 years&#xD;
             old; resided in Northern Manhattan for at least 3 months, in a household with a&#xD;
             telephone.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  For this analysis we excluded participants with diabetes mellitus at baseline, defined&#xD;
             by the participant's self-reported diabetes, use of insulin or oral anti-diabetic&#xD;
             medication, or fasting glucose at least 126 mg/dl. We also excluded participants&#xD;
             missing data for soda consumption, and those with improbable total daily kilocalories&#xD;
             based on food frequency responses.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Ralph L Sacco, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>January 10, 2023</last_update_submitted>
  <last_update_submitted_qc>January 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Ralph L Sacco, MD MS</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>race</keyword>
  <keyword>diet</keyword>
  <keyword>diabetes</keyword>
  <keyword>ethnicity</keyword>
  <keyword>myocardial infarction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03266952
org study id: 20070212
secondary id: R37NS029993
nct id: NCT03266952
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
Stroke remains a major public health problem with a disproportionate impact on blacks and
      Hispanics.

      Studies in Northern Manhattan have demonstrated that blacks and Hispanics have a greater
      stroke incidence and more frequently have small vessel and intracranial atherosclerotic
      stroke than whites.

      The reasons for these race/ethnic disparities are not entirely clear. Enrollment of a
      population-based, prospective cohort of 3298 stroke-free adults was completed in 2001 and
      annual followup 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 followup and outcome detection and expansion of data collection in
      this cohort. The aims are to evaluate the relationship between vascular outcomes (stroke, MI,
      and vascular death) and insulin resistance, carotid intima-media thickness, carotid
      distensibility, and quantitative 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. The strengths of this cohort study are the
      wealth of baseline data already assembled, the triethnic composition residing in the same
      community, the outstanding followup record, the evaluation of putative risk factors, and the
      innovative assessment of MRI subclinical disease and carotid subclinical disease. The study
      primary hypotheses are:1. To determine the independent association of insulin resistance
      among nondiabetics and the incidence of stroke, as well as stroke, MI or vascular death,
      after adjusting for known modifiable risk factors such as hypertension, lipids, cigarettes,
      and alcohol. 2.

      To evaluate the independent association of subclinical carotid disease (carotid intima-media
      thickness and carotid distensibility) and the incidence of stroke, MI or vascular death after
      adjusting for conventional modifiable vascular risk factors, as well as novel vascular risk
      factors such as homocysteine, high density lipoprotein (HDL) subpopulations, and insulin
      resistance.3. To compare the prevalence of subclinical vascular brain disease as measured by
      quantitative MRI, including white matter hyperintensities, silent infarcts, and silent
      cerebral microbleeds, in each race/ethnic subgroup and determine the association between
      subclinical brain disease and modifiable vascular risk factors measured up to 10 years prior
      to MRI. Vascular risk factors will include baseline and repeated measures of conventional
      modifiable conditions such as hypertension, diabetes, lipid levels, cigarette smoking,
      physical activity, alcohol use, as well as less-well documented factors such as homocysteine,
      HDL subpopulations, and insulin resistance. 4. To determine the relationship between
      subclinical vascular brain diseases and cognitive impairment, particularly diminished
      performance in frontal executive tests, and whether these MRI findings help explain cognitive
      performance differences among whites, blacks and Hispanics after adjusting for age and
      education.5. To explore whether subclinical vascular brain diseases are important predictors
      of stroke, MI or vascular death. Beginning in Summer 2005, some new aims were added as
      follows: 1) to determine whether aortic arch abnormalities and/or cardiac abnormalities,
      and/or 24hour blood pressure levels and changes, are independently associated with silent
      brain infarcts in the elderly; 2) to determine the risk of symptomatic stroke, myocardial
      infarction and vascular death associated with aortic/cardiac/24hour blood pressure
      abnormalities. As of 2010 the investigators will be collaborating with other institutions
      under the NINDS Ischemic Stroke Genetics (ISG) study. The aims of the NINDS Ischemic Stroke
      Genetics Study (NINDS ISG Study; NIH Grant 1 U01 NS06920801) are to:1) Assemble ischemic
      stroke phenotypic data and high quality DNA data from 10 stroke studies. (Participating
      studies in the NINDS ISG Study: Ischemic Stroke Genetics Study; Siblings with Ischemic Stroke
      Study; Greater Cincinnati/Northern Kentucky Stroke Study; Genes Affecting Stroke Risk and
      Outcome Study/Bugher Network Study; Northern Manhattan Study; Baltimore/Washington Young
      Stroke Study; Heart and Vascular Health Stroke Study; Nurses Health Study; Reasons for
      Geographic and Racial Differences in Stroke; Women's Health Initiative). This collaboration
      has access to 7,033 cases of ischemic stroke and 23,411 study-specific controls. 2) Test for
      associations with ischemic stroke and its subtypes in the NINDS ISG Study. 3) Replicate and
      extend associations detected in Aim 1.2 above by taking advantage of other genomewide
      association studies conducted by other members of the Ischemic Stroke Genetics studies.
observational model: Cohort
time perspective: Prospective
measure: Incidence of Stroke
time frame: 24 years
description: 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"
measure: Incidence of myocardial infarction
time frame: 24 years
description: 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.
measure: Incidence of vascular death
time frame: 24 years
description: 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
measure: Scoring cognitive impairment
time frame: Mean of 6 years after baseline
description: A neuropsychological battery was administered and participants were scored on 4 cognitive domains: semantic memory, episodic memory, executive function, processing speed
measure: Incidence of diabetes
time frame: 24 years
description: Self-reported incidence of diabetes
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
last name: Ralph L Sacco, MD
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Ralph L Sacco, MD MS
investigator title: Principal Investigator
mesh term: Stroke
mesh term: Myocardial Infarction
mesh term: Infarction
sharing ipd: No