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A Comparison of Hemorrhagic and Ischemic Strokes Among Blacks and Whites (GCNKSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00642213
Recruitment Status : Active, not recruiting
First Posted : March 24, 2008
Last Update Posted : May 5, 2021
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Brett Kissela, University of Cincinnati

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
Ischemic Stroke TIA Hemorrhage

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.

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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 : July 1993
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : April 1, 2025

Resource links provided by the National Library of Medicine

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 ( 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.

Primary Outcome Measures :
  1. mRS [ Time Frame: discharge or 30 days ]
    modified Rankin Scale

Secondary Outcome Measures :
  1. mortality [ Time Frame: 1 year ]
    entire patient population checked for possible death record via NDI/CDC

Other Outcome Measures:
  1. 2020 Stroke population mRS [ Time Frame: 3 month, 6 month, and 1 year ]
    we will collect 3 months, 6 months, and 1 year mRS outcomes on the 2020 stroke patients

Biospecimen Retention:   Samples With DNA
We have collected blood and/or buccal samples from an interviewed cohort during years 1999,2005, and 2010.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Prospective cohort:Ischemic stroke patient in 1999/2005/2010 that resides in the GCNK area.

Retrospective cohorts: All stroke and TIA events occurring during the following study periods: 1993-94, 1999, 2005, 2010, and 2015. This group is ALL stroke patients of any age that resides in our 5 county region.


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

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 identifier (NCT number): NCT00642213

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United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0525
Sponsors and Collaborators
University of Cincinnati
National Institute of Neurological Disorders and Stroke (NINDS)
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Principal Investigator: Brett M Kissela, MD University of Cincinnati
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Brett Kissela, Principal Investigator, University of Cincinnati Identifier: NCT00642213    
Other Study ID Numbers: UC IRB 2013-3959
R01NS030678 ( U.S. NIH Grant/Contract )
First Posted: March 24, 2008    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: we have a website: where de-identified data can be requested via an approval process
Supporting Materials: Study Protocol
Time Frame: Current study data through 2010 is available via website. 2015 data will be available at a future date.
Access Criteria: please see website below
Keywords provided by Brett Kissela, University of Cincinnati:
risk factors
Additional relevant MeSH terms:
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Ischemic Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia