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A Comparison of Hemorrhagic and Ischemic Strokes Among Blacks and Whites (GCNKSS)
This study is ongoing, but not recruiting participants.
First Received: March 19, 2008   No Changes Posted
Sponsors and Collaborators: University of Cincinnati
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: University of Cincinnati
ClinicalTrials.gov Identifier: NCT00642213
  Purpose

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.

For 1/1/2005 to 12/31/2005, we will identify every hospitalized or autopsied stroke and transient ischemic attack (TIA) at all 17 regional hospitals. We will also estimate the number of non-hospitalized strokes and TIAs by screening for potential cases at 143 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 the same methodology used during 1993-94 and 1999 as well as with cases of intracerebral hemorrhage (ICH) and subarachnoid hemorrhage (SAH) identified during 1988.

In addition, we will interview 500 ischemic stroke patients and/or their families, 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 will also obtain genetic material via a blood sample.


Condition
Ischemic Stroke
TIA
Hemorrhage

Drug Information available for: 1,4-Benzenediol
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: A Comparison of Hemorrhagic and Ischemic Strokes Among Blacks and Whites: A Population-Based Study in Cincinnati, Ohio

Further study details as provided by University of Cincinnati:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

We have a prospectively collected cohort of 502 of which 450 provided a blood sample for DNA to be processed and stored at Coriell.


Enrollment: 502
Study Start Date: July 2004
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
We prospectively collected 502 ischemic stroke patients who could agree to provide a sample for DNA (450). The cohort data consists of a baseline interview, medical record abstraction and a 3m and 12m followup interview.
2
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 the year 2005.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • ischemic stroke
  • occurred in 2005
  • >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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00642213

Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0525
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Brett M Kissela, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: University of Cincinnati, Dept. of Neurology ( Brett Kissela, M.D. )
Study ID Numbers: NS30678, NIH GRANT:NS30678
Study First Received: March 19, 2008
Last Updated: March 19, 2008
ClinicalTrials.gov Identifier: NCT00642213     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
stroke
ischemic
TIA
hemorrhage
incidence
case-fatality
risk factors
genetic

Study placed in the following topic categories:
Radiation-Protective Agents
Antioxidants
Cerebral Infarction
Stroke
Hydroquinone
Vascular Diseases
Central Nervous System Diseases
Ischemia
Hemorrhage
Brain Diseases
Cerebrovascular Disorders
Brain Ischemia
Brain Infarction
Infarction

Additional relevant MeSH terms:
Radiation-Protective Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Cerebral Infarction
Physiological Effects of Drugs
Hydroquinone
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Ischemia
Hemorrhage
Brain Diseases
Protective Agents
Cerebrovascular Disorders
Pharmacologic Actions
Pathologic Processes
Brain Ischemia
Cardiovascular Diseases
Brain Infarction

ClinicalTrials.gov processed this record on May 07, 2009