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: February 25, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 19, 2008

Last Updated Date

February 25, 2013

Start Date ^ICMJE

July 1993

Estimated Primary Completion Date

June 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

mRS [ Time Frame: 30 days ] [ Designated as safety issue: No ]

modified Rankin Scale

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00642213 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Comparison of Hemorrhagic and Ischemic Strokes Among Blacks and Whites

Official Title ^ICMJE

A Comparison of Hemorrhagic and Ischemic Strokes Among Blacks and Whites: A Population-Based Study in Cincinnati, Ohio

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

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.

Sampling Method

Non-Probability Sample

Study Population

Prospective cohort:Ischemic stroke patient in 1999/2005/2010 that resides in the GCNK area.

Condition ^ICMJE

Ischemic Stroke
TIA
Hemorrhage

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

516

Estimated Completion Date

June 2014

Estimated Primary Completion Date

June 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00642213

Other Study ID Numbers ^ICMJE

NS30678, NIH GRANT:NS30678

Has Data Monitoring Committee

Responsible Party

Brett Kissela, University of Cincinnati

Study Sponsor ^ICMJE

University of Cincinnati

Collaborators ^ICMJE

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators ^ICMJE

Principal Investigator:

Brett M Kissela, MD

University of Cincinnati

Information Provided By

University of Cincinnati

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top