ROSE-Longitudinal Assessment With Neuroimaging (ROSE-LAWN)

Recovery and Outcomes From Stroke-Longitudinal Assessment With Neuroimaging

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.

Study Overview

• Status: Recruiting
• Conditions: Intracerebral Hemorrhage

Detailed Description

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 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.

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Lee A Gilkerson, RN, BSN; Phone Number: 5139191822; Email: Lee.gillkerson@uc.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois Chicago
      • Contact: Maureen Hillman; Phone Number: 312-355-3863; Email: hillmann@uic.edu
      • Principal Investigator: Fernando Testai, M.D.
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Recruiting
      • Baptist Health Louisville
      • Contact: Karin Cryan; Phone Number: 502-259-5564; Email: karin.cryan@BHSI.COM
      • Principal Investigator: Ranjit Bagga, M.D.
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland
      • Contact: Julia Mosher; Phone Number: 410-706-1902; Email: julia.mosher@som.umaryland.edu
      • Contact: Natalie Fecteau; Phone Number: 410-706-1902; Email: NFecteau@som.umaryland.edu
      • Principal Investigator: Steven Kittner, M.D.
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University
      • Contact: Angela Velazquez; Phone Number: 212-305-6071; Email: aqv2113@cumc.columbia.edu
      • Principal Investigator: David Roh, M.D.
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University
      • Contact: Andreea Podgoreanu; Email: andrea.podgoreanu@duke.edu
      • Principal Investigator: Michael L James, M.D.
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Recruiting
      • University of Cincinnati
      • Contact: Lee A Gilkerson, RN, BSN; Phone Number: 513-558-0122; Email: Lee.gilkerson@uc.edu
      • Contact: Tyler P Behymer, BS; Phone Number: 513-558-0122; Email: Tyler.behymer@uc.edu
      • Principal Investigator: Daniel Woo, M.D.,MS
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist
      • Contact: Jennifer Meeks, MS; Email: jmeeks@houstonmethodist.org
      • Principal Investigator: Farhaan Vahidy, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of neuroimaging markers associated with progressive cognitive decline	The baseline and planned follow-up MRI include tractography to assess cortical to cortical tract integrity as well as inflammatory microstructural quantitative measurements. The follow-up MR tractography biomarkers will be compared to the acute/baseline MRI to determine if deterioration (particularly the contralateral hemisphere) correlates with progressive cognitive impairment. If the progressive deterioration in survivors of ICH is global, the contralateral hemisphere should also demonstrate progressive neuroimaging markers of deterioration.	Ongoing/completed by September 2024

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Collaborators: University of Maryland, Baltimore; Columbia University; National Institute of Neurological Disorders and Stroke (NINDS); University of Illinois at Chicago; Duke University; The Methodist Hospital Research Institute; Baptist Health, Louisville
• Investigators: Principal Investigator: Daniel Woo, MD, MS, State University of New York at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Intracerebral Hemorrhage; Hemorrhagic Stroke, Intracerebral; Outcomes after Stroke; Intracerebral hematoma
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: R01NS120493-02 (U.S. NIH Grant/Contract); R01NS120493 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No