GCNKSS: A Comparison of Hemorrhagic and Ischemic Strokes Among Blacks and Whites

Sponsor
University of Cincinnati (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00642213
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
1,500
1
381
3.9

Study Details

Study Description

Brief Summary

Our primary goal is to study temporal trends in the incidence rate, causes, treatment, and outcome of stroke among a large biracial metropolitan population of 1,349,351, of whom 215,611 (15%) are black (2000 Census). Such data are critical for the planning, intervention, and evaluation of public health efforts to decrease the mortality and morbidity due to stroke in the United States.

We have completed this goal for 1993-94, 1999, 2005, 2010 and 2015. We are in the process of collecting this data for 2020. In the 2020 study period we will also be ascertaining 3 year recurrence rates for all incident stroke events.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    For calendar years 1993-94, 1999, 2005, 2010, 2015, and 2020 we will or have identified every hospitalized or autopsied stroke and transient ischemic attack (TIA) at all regional hospitals in our region. We will also estimate the number of non-hospitalized strokes and TIAs by screening for potential cases at more than 100 outpatient sites throughout five counties in Greater Cincinnati/Northern Kentucky. We plan to identify and abstract detailed information from the medical record for every potential case. These results will be compared with data from all stroke patients identified by similar methodology in all study periods.

    In addition, we have interviewed 1500 ischemic stroke patients and/or their families in the study periods 1999-2010 to obtain detailed information including demographic information, functional outcome and quality of life, access to and type of rehabilitation therapy, social support, caregiver availability and health status, access to post-hospital care, health insurance status, current health status, medications, prior risk factors, and knowledge about stroke signs and symptoms. We also obtained genetic material via a blood sample for most of this cohort.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Comparison of Hemorrhagic and Ischemic Strokes Among Blacks and Whites: A Population-Based Study in Cincinnati, Ohio
    Study Start Date :
    Jul 1, 1993
    Anticipated Primary Completion Date :
    Apr 1, 2025
    Anticipated Study Completion Date :
    Apr 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    ischemic stroke sample with DNA

    We prospectively collected 450(1999), 502(2005), and 512(2010) ischemic stroke patients who agreed to participate and also most provided a sample for DNA. The cohort data consists of a baseline interview, medical record abstraction and various timeframes of followup interviews from 3 months to 3 years. See website (www.gcnkss.com for data forms)

    stroke data from medical record review

    The second part of the study is a retrospective medical record review of all potential ischemic strokes, TIAs, and Hemorrhagic strokes in our 5 county region that occurred in all study years.

    Outcome Measures

    Primary Outcome Measures

    1. mRS [discharge or 30 days]

      modified Rankin Scale

    Secondary Outcome Measures

    1. mortality [1 year]

      entire patient population checked for possible death record via NDI/CDC

    Other Outcome Measures

    1. 2020 Stroke population mRS [3 month, 6 month, and 1 year]

      we will collect 3 months, 6 months, and 1 year mRS outcomes on the 2020 stroke patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • ischemic stroke

    • occurred in 1999/2005/2010

    • 18 years old

    • resides in 5 county region

    Exclusion Criteria:
    • <18 years old

    • resides outside 5 county region

    • inability to consent or have legal proxy consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Cincinnati Cincinnati Ohio United States 45267-0525

    Sponsors and Collaborators

    • University of Cincinnati
    • National Institute of Neurological Disorders and Stroke (NINDS)

    Investigators

    • Principal Investigator: Brett M Kissela, MD, University of Cincinnati

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Brett Kissela, Principal Investigator, University of Cincinnati
    ClinicalTrials.gov Identifier:
    NCT00642213
    Other Study ID Numbers:
    • UC IRB 2013-3959
    • R01NS030678
    First Posted:
    Mar 24, 2008
    Last Update Posted:
    May 5, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Brett Kissela, Principal Investigator, University of Cincinnati
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 5, 2021