Clinical trial NCT00642213: A Comparison of Hemorrhagic and Ischemic Strokes Among Blacks and Whites
Official title: A Comparison of Hemorrhagic and Ischemic Strokes Among Blacks and Whites: A Population-Based Study in Cincinnati, Ohio
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ischemic Stroke
TIA
Hemorrhage
Keywords: stroke
ischemic
TIA
hemorrhage
incidence
case-fatality
risk factors
genetic
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2008-03-24
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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, 2015 and 2020. This group is ALL stroke patients of any age that resides in our 5 county region.

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.

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: 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.

Eligibility 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

Primary outcomes:
measure: mRS
timeFrame: discharge or 30 days
Secondary outcomes:
measure: mortality
timeFrame: 1 year
Other outcomes:
measure: 2020 Stroke population mRS
timeFrame: 3 month, 6 month, and 1 year
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Brett M Kissela, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.