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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Brett Kissela, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00642213
First received: March 19, 2008
Last updated: February 25, 2013
Last verified: February 2013
  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 calendar years 1993-94, 1999, 2005, and 2010 we will identify 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 interview 500 ischemic stroke patients and/or their families(each study year period starting in 1999), 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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • mRS [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    modified Rankin Scale


Secondary Outcome Measures:
  • mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

In 2010 we have a prospectively collected a cohort of 516 of which 396 provided a blood sample for DNA to be stored at the University of Cincinnati. We have 450 samples stored from the 2005 cohort.


Enrollment: 516
Study Start Date: July 1993
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
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 3m to 3yrs.
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 all study years.

  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 1999/2005/2010 that resides in the GCNK area.

Criteria

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
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, see Learn About Clinical Studies.

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: Brett Kissela, Principal Investigator, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00642213     History of Changes
Other Study ID Numbers: NS30678, NIH GRANT:NS30678
Study First Received: March 19, 2008
Last Updated: February 25, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 20, 2014