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Recruiting NCT05089331

NCT05089331 ROSE-Longitudinal Assessment With Neuroimaging

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Clinical Trial Summary
NCT ID NCT05089331
Status Recruiting
Phase
Sponsor State University of New York at Buffalo
Condition Intracerebral Hemorrhage
Study Type OBSERVATIONAL
Enrollment 250 participants
Start Date 2020-09-30
Primary Completion 2026-03-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL

Eligibility Fast-Check

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 250 participants in total. It began in 2020-09-30 with a primary completion date of 2026-03-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Age 18 years or greater, fulfillment of the criteria for Deep, Subcortical or Lobar Intracerebral Hemorrhage * 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: * Brainstem or Cerebellar ICH * Patients Severely Affected by the ICH, Early Mortality, Hospice, or Withdraw of Care NOT eligible for ROS

Contact & Investigator

Central Contact

Lee A Gilkerson, RN, BSN

✉ Lee.gillkerson@uc.edu

📞 5139191822

Principal Investigator

Daniel Woo, MD, MS

PRINCIPAL INVESTIGATOR

State University of New York at Buffalo

Frequently Asked Questions

Who can join the NCT05089331 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Intracerebral Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05089331 currently recruiting?

Yes, NCT05089331 is actively recruiting participants. Contact the research team at Lee.gillkerson@uc.edu for enrollment information.

Where is the NCT05089331 trial being conducted?

This trial is being conducted at Chicago, United States, Louisville, United States, Baltimore, United States, New York, United States and 3 additional locations.

Who is sponsoring the NCT05089331 clinical trial?

NCT05089331 is sponsored by State University of New York at Buffalo. The principal investigator is Daniel Woo, MD, MS at State University of New York at Buffalo. The trial plans to enroll 250 participants.

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