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...
Date First Received: March 19, 2008
Last Updated: March 19, 2008
Verified by: University of Cincinnati, March 2008
Clinical Trial Phase: N/A | Start Date: July 2004
Overall Status: Active, not recruiting
Estimated Enrollment: 502
Brief Summary
Official Title: “A Comparison of Hemorrhagic and Ischemic Strokes Among Blacks and Whites: A Population-Based Study in Cincinnati, Ohio”
Condition Keyword(s):
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.
Study Type: Observational
Study Design: Cohort, Prospective
Study Primary Completion Date: June 2009
Arms, Groups and Cohorts in this Clinical Trial
- : 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.
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University of Cincinnati
Overall Clinical Trial Officials and Contacts
Brett M Kissela, MD Principal Investigator University of Cincinnati
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00642213
Study ID Number: NS30678
ClinicalTrials.gov Identifier: NCT00642213
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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