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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Brett Kissela, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00642213
First received: March 19, 2008
Last updated: May 19, 2016
Last verified: May 2016
  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.

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


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
We have collected blood and/or buccal samples from an interviewed cohort during years 1999,2005, and 2010.

Enrollment: 1200
Study Start Date: July 1993
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
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 3m to 3yrs. 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.

Detailed Description:

For calendar years 1993-94, 1999, 2005, 2010, and 2015 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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

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.

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
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Brett M Kissela, MD University of Cincinnati
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brett Kissela, Principal Investigator, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00642213     History of Changes
Other Study ID Numbers: UC IRB 2013-3959  R01NS030678 
Study First Received: March 19, 2008
Last Updated: May 19, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: we have a website: www.gcnkss.com where de-identified data can be requested via an approval process

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

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

ClinicalTrials.gov processed this record on August 24, 2016