Study Results
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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RECRUITING
250 participants
OBSERVATIONAL
2020-09-30
2026-06-01
Brief Summary
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Detailed Description
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Specific Aim #1: Determine if progressive cognitive impairment correlates with an increase in established markers of cerebral small vessel disease(CSVD) and cerebral amyloid angiopathy(CAA) (white matter disease, siderosis and microbleeds).
Hypothesis #1: Incidence of progressive cognitive impairment after ICH will be associated with an increase in total burden of small vessel disease (including white matter disease (WMD), microbleeds or siderosis, perivascular spaces, lacunar infarcts and atrophy).
Specific Aim #2: Determine if inflammation as measured by RNA-sequencing markers of inflammation correlates with progressive cognitive impairment.
Hypothesis #2: Interleukin-8 related inflammation will be associated with incidence of cognitive impairment.
Specific Aim #3: In this exploratory aim, we seek to identify novel neuroimaging markers associated with progressive cognitive decline.
Exploratory Hypothesis #3: Contralateral hemispheric diffusion tensor imaging (DTI) measures and cortical to cortical tract integrity will decline in association with progressive cognitive impairment.
Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Study Groups
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Participants will be recruited from the GERFHS/ROSE Study
Participants will be recruited who have had a hemorrhagic stroke and have been enrolled into the Genetic and Environmental Risk Factors for Hemorrhagic Stroke Study/Recovery and Outcomes from Stroke study, who live in the area of University of Cincinnati, University of Maryland, Duke University, Columbia University and University of Chicago Illinois, Baptist Health Louisville and Houston Methodist. The participant's age must be18 years or greater. The participant or legal representative must be able to provide informed consent, and the racial/ethnic category of participants should be Caucasian, African American or Hispanic.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* No evidence of trauma, vascular malformation or aneurysm, or brain tumor as a cause of ICH.
* Ability of the patient or legal representative to provide informed consent
Exclusion Criteria
* Patients Severely Affected by the ICH, Early Mortality, Hospice, or Withdraw of Care NOT eligible for ROS
18 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Maryland, Baltimore
OTHER
Duke University
OTHER
Columbia University
OTHER
University of Illinois at Chicago
OTHER
Baptist Health, Louisville
OTHER
The Methodist Hospital Research Institute
OTHER
State University of New York at Buffalo
OTHER
Responsible Party
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Daniel Woo
M.D.,M.S., Professor
Principal Investigators
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Daniel Woo, MD, MS
Role: PRINCIPAL_INVESTIGATOR
State University of New York at Buffalo
Locations
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University of Illinois Chicago
Chicago, Illinois, United States
Baptist Health Louisville
Louisville, Kentucky, United States
University of Maryland
Baltimore, Maryland, United States
Columbia University
New York, New York, United States
Duke University
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Houston Methodist
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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