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ROSE-Longitudinal Assessment With Neuroimaging

Recovery and Outcomes From Stroke-Longitudinal Assessment With Neuroimaging

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05089331
Acronym
ROSE-LAWN
Enrollment
250
Registered
2021-10-22
Start date
2020-09-30
Completion date
2027-06-01
Last updated
2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracerebral Hemorrhage

Keywords

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

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.

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.

Interventions

None listed

Sponsors

State University of New York at Buffalo
Lead SponsorOTHER
National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
University of Maryland, Baltimore
CollaboratorOTHER
Duke University
CollaboratorOTHER
Columbia University
CollaboratorOTHER
University of Illinois at Chicago
CollaboratorOTHER
Baptist Health, Louisville
CollaboratorOTHER
The Methodist Hospital Research Institute
CollaboratorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Determination of whether progressive cognitive impairment correlates with CVD and AA markersOngoing/completed by September 2024Each 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.
Determination of whether inflammation as measured by RNA-sequencing markers of inflammation correlates with progressive cognitive impairmentOngoing/completed by September 2024The 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDaniel Woo, MD, MS

State University of New York at Buffalo

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026