ROSE-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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Illinois Chicago, Chicago, Illinois, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: Ongoing/completed by September 2024

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

Time frame: Ongoing/completed by September 2024

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.

Other outcomes

Identification of neuroimaging markers associated with progressive cognitive decline

Time frame: Ongoing/completed by September 2024

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.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Collaborators

Baptist Health, Louisville
Columbia University
Duke University
National Institute of Neurological Disorders and Stroke (NINDS)
The Methodist Hospital Research Institute
University of Illinois at Chicago
University of Maryland, Baltimore

Registry information

Official study title

Recovery and Outcomes From Stroke-Longitudinal Assessment With Neuroimaging

Acronym: ROSE-LAWN

Important dates

Study start: 2020
Primary completion: 2027
Study completion: 2027
First posted: Oct 22, 2021
Registry last updated: Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting