ROSE-Longitudinal Assessment With Neuroimaging

Intracerebral Hemorrhage Clinical Trial

— ROSE-LAWN  

Official title:

Recovery and Outcomes From Stroke-Longitudinal Assessment With Neuroimaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05089331
• Other study ID #: R01NS120493-02
• Secondary ID: R01NS120493
• Status: Recruiting
• Start date: September 30, 2020
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2023
• Source: University of Cincinnati
• Contact: Lee A Gilkerson, RN, BSN
• Phone: 5139191822
• Email: Lee.gillkerson[@]uc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	University of Illinois Chicago	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Duke University	Durham	North Carolina
United States	Houston Methodist	Houston	Texas
United States	Baptist Health Louisville	Louisville	Kentucky
United States	Columbia University	New York	New York

Sponsors (8)

Lead Sponsor	Collaborator
University of Cincinnati	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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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