A Comparison of Hemorrhagic and Ischemic Strokes Among Blacks and Whites (GCNKSS)
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|ClinicalTrials.gov Identifier: NCT00642213|
Recruitment Status : Active, not recruiting
First Posted : March 24, 2008
Last Update Posted : May 5, 2021
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|
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 Type :||Observational|
|Actual Enrollment :||1500 participants|
|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|
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.
- mRS [ Time Frame: discharge or 30 days ]modified Rankin Scale
- mortality [ Time Frame: 1 year ]entire patient population checked for possible death record via NDI/CDC
- 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
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): NCT00642213
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267-0525|
|Principal Investigator:||Brett M Kissela, MD||University of Cincinnati|