A Comparison of Hemorrhagic and Ischemic Strokes Among Blacks and Whites

NCT ID: NCT00642213

Last Updated: 2024-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

1993-07-31

Study Completion Date

2025-06-30

Brief Summary

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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, 2010 and 2015. We are in the process of collecting this data for 2020. In the 2020 study period we will also be ascertaining 3 year recurrence rates for all incident stroke events.

Detailed Description

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For calendar years 1993-94, 1999, 2005, 2010, 2015, and 2020 we will or have identified 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.

Conditions

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Ischemic Stroke TIA Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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 3 months to 3 years. See website (www.gcnkss.com for data forms)

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Brett Kissela

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brett M Kissela, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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Gillard PJ, Sucharew H, Kleindorfer D, Belagaje S, Varon S, Alwell K, Moomaw CJ, Woo D, Khatri P, Flaherty ML, Adeoye O, Ferioli S, Kissela B. The negative impact of spasticity on the health-related quality of life of stroke survivors: a longitudinal cohort study. Health Qual Life Outcomes. 2015 Sep 29;13:159. doi: 10.1186/s12955-015-0340-3.

Reference Type DERIVED
PMID: 26415945 (View on PubMed)

Other Identifiers

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R01NS030678

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UC IRB 2013-3959

Identifier Type: -

Identifier Source: org_study_id

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