ROSE-Longitudinal Assessment With Neuroimaging
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- State University of New York at Buffalo
- Study ID
- NCT05089331
- Status
- Recruiting
Conditions
- Intracerebral Hemorrhage
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
The investigators will perform follow-up on 250 of 500 cases recruited into the ROSE study of cases with deep and lobar intracerebral hemorrhage to perform advanced neuroimaging at 12-24 months post stroke, and evaluations of motor and cognitive function at baseline, 6 months after baseline, and 12 months after baseline to determine predictors of recovery, progressive cognitive or functional impairment. The investigators propose to leverage the recruitment, DNA, RNA-seq and baseline advanced neuroimaging cohort of ROSE to obtain long-term neuroimaging and identical assessments longitudinally to address critical questions regarding the progressive decline of patients 12 to 24 months post intracerebral hemorrhage (ICH) with long term cognitive follow-up to 36 months on average. This proposal would represent the largest, and longest advanced neuroimaging and RNA-sequencing evaluation after ICH to date.
Key Dates
- Start date
- Sep 30, 2020
- Status verified
- Jul 2025
- Primary completion
- Mar 1, 2026
- Completion
- Jun 1, 2026
Study Design
- Enrollment
- 250 participants (estimated)
Arms
- Arm: Participants will be recruited from the GERFHS/ROSE StudyParticipants 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.
Primary Outcome Measure
Determination of whether progressive cognitive impairment correlates with CVD and AA markers [ Time Frame: Ongoing/completed by September 2024 ]
Central Contacts
- Lee A Gilkerson, RN, BSN5139191822
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Illinois Chicago | Chicago | Illinois | 60612 | Fernando Testai, M.D. (PRINCIPAL_INVESTIGATOR) |
| Baptist Health Louisville | Louisville | Kentucky | 40207 | Ranjit Bagga, M.D. (PRINCIPAL_INVESTIGATOR) |
| University of Maryland | Baltimore | Maryland | 21201 | Steven Kittner, M.D. (PRINCIPAL_INVESTIGATOR) |
| Columbia University | New York | New York | 10032 | David Roh, M.D. (PRINCIPAL_INVESTIGATOR) |
| Duke University | Durham | North Carolina | 27710 | Andreea Podgoreanu Michael L James, M.D. (PRINCIPAL_INVESTIGATOR) |
| University of Cincinnati | Cincinnati | Ohio | 45267 | Daniel Woo, M.D.,MS (PRINCIPAL_INVESTIGATOR) |
| Houston Methodist | Houston | Texas | 77030 | Jennifer Meeks, MS Farhaan Vahidy, M.D. (PRINCIPAL_INVESTIGATOR) |
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