ROSE-Longitudinal Assessment With Neuroimaging

NCT05089331 | Recruiting

• 2 other identifiers: R01NS120493-02R01NS120493
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 7

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.

Conditions

Intracerebral Hemorrhage

Keywords

Hemorrhagic Stroke, Intracerebral; Intracerebral Hemorrhage; Outcomes after Stroke; Intracerebral hematoma

Outcome Measures

Primary Outcomes (2)

• Determination of whether progressive cognitive impairment correlates with CVD and AA markers

  Each subject has a baseline # Tesla (3T) MRI with DTI along with blinded central measurement of cerebral small vessel disease parameters. The current proposal is specifically designed to address these potential hypotheses by a comprehensive evaluation of detailed neurocognitive evaluations, baseline and long-term follow-up neuroimaging markers of CSVD and CAA as well as RNA sequencing of serum leukocytes for markers of inflammation.

  Ongoing/completed by September 2024

• Determination of whether inflammation as measured by RNA-sequencing markers of inflammation correlates with progressive cognitive impairment

  The current proposal is specifically designed to address these potential hypotheses by a comprehensive evaluation of detailed neurocognitive evaluations, baseline and long-term follow-up neuroimaging markers of CSVD and CAA as well as RNA sequencing of serum leukocytes for markers of inflammation. If the occurrence of progressive cognitive decline is caused by inflammation from the ICH itself, those with cognitive decline should have chronically increased expression of inflammation compared to those without cognitive decline, where inflammatory markers normalize. Our preliminary data suggests a role of interleukin-8 as increased in expression after ICH.

  Ongoing/completed by September 2024

Other Outcomes (1)

• Identification of neuroimaging markers associated with progressive cognitive decline

  Ongoing/completed by September 2024

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants already enrolled in Genetic and Environmental Risk Factors for Hemorrhagic Stroke/Recovery and Outcomes from Stroke (GERFHS/ROSE) study

You may qualify if:

• 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

You may not qualify if:

• Brainstem or Cerebellar ICH
• Patients Severely Affected by the ICH, Early Mortality, Hospice, or Withdraw of Care NOT eligible for ROS

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• University of Maryland, Baltimore: collaborator
• Duke University: collaborator
• Columbia University: collaborator
• University of Illinois at Chicago: collaborator
• Baptist Health, Louisville: collaborator
• The Methodist Hospital Research Institute: collaborator

Study Sites (7)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

RECRUITING

Baptist Health Louisville

Louisville, Kentucky, 40207, United States

RECRUITING

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

Columbia University

New York, New York, 10032, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

Houston Methodist

Houston, Texas, 77030, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, DNA, RNA and Plasma

MeSH Terms

Conditions

Cerebral Hemorrhage; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke

Study Officials

• Daniel Woo, MD, MS

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lee A Gilkerson, RN, BSN

CONTACT

5139191822; Lee.gillkerson@uc.edu

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.,M.S., Professor

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 22, 2021
• Study Start: September 30, 2020
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)