Biomarkers for Cognitive Decline in Intracerebral Hemorrhage

August 6, 2025 updated by: Rush University Medical Center

Silent Brain Infarcts in Spontaneous Intracerebral Hemorrhage as a Prognostic Biomarker for Vascular Contributions to Cognitive Impairment and Dementia (VCID)

The goal of this clinical trial is to see if silent brain infarcts (SBIs), or stroke-like symptoms detectable during brain imaging, are a possible contributor to cognitive decline for patients diagnosed with spontaneous intracerebral hemorrhage (sICH), or blood clot in the brain. The main questions it aims to answer are

  • if SBIs in sICH are associated with a lower cognitive level and more rapid cognitive decline
  • if SBIs in sICH are associated with certain findings on brain imaging
  • if SBIs in sICH are associated with higher inflammation measured by certain blood tests

Participants will undergo

  • cognitive testing during hospitalization, and at 3, 6 and 12 months after the sICH
  • Magnetic Resonance Imaging (MRI) of the brain during hospitalization and 12 months after the sICH
  • blood draws during hospitalization and at 3, 6 and 12 months after the sICH

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This proposal's objective is to establish SBIs (silent brain infarct) as an early, pathophysiologically plausible neuroimaging biomarker for VCID (vascular contributions to cognitive impairment and dementia) in sICH (spontaneous intracerebral hemorrhage) patients. To attain the overall objective, we will recruit a cohort of 118 sICH participants over 3 years and longitudinally measure cognitive function, WMH volumetric progression, and serum suPAR levels. Aim #1: To test the hypothesis that SBIs in sICH are associated with a lower cognitive level and more rapid cognitive decline. Approach: In sICH patients with and without SBIs, we will compare global cognition (primary analysis) and multiple cognitive domains (secondary analysis) at hospitalization, and at 3 months, 6 months, and 12 months after discharge using a comprehensive cognitive battery. Aim #2: To test the hypothesis that SBIs in sICH are associated with more rapid WMH (white matter hyperintensities) progression as measured by serial MRI (magnetic resonance imaging). Approach: In sICH patients with and without SBIs, we will compare the absolute volumetric change in WMH using a novel imaging analysis algorithm on serial 3-Tesla brain MRI at hospitalization and at 12 months after discharge. Aim #3: To test the hypothesis that SBIs in sICH are associated with higher chronic systemic inflammation as measured by serum suPAR. Approach: In sICH patients with and without SBIs, we will compare serum levels of suPAR at hospitalization, and at 3 months, 6 months, and 12 months after discharge.

This study will be a prospective longitudinal study of sICH patients comparing those with and without SBIs. All patients with primary sICH are admitted to Rush University Medical Center's (RUMC) Neurosciences Intensive Care Unit and managed by a multi-disciplinary team of neurologists and neurosurgeons according to a standardized protocol based on current guidelines. Primary sICH will be defined as either hypertensive or related to cerebral amyloid angiopathy as diagnosed using the Boston Criteria version 2.0. This differs from secondary sICH, defined as hemorrhage due to vascular malformation, coagulopathy, trauma, malignancy, or reversible vasculopathy. Before hospital discharge, participants will receive baseline cognitive testing, MRI brain, and suPAR (soluble urokinase-type plasminogen activator receptor) serology sampling. After discharge from the hospital, participants will follow up in RUMC's Comprehensive Stroke Clinic at 3 months as part of their routine stroke care per our center's protocol. At the 3-month visit, participants will receive cognitive testing and provide suPAR serology. Participants will complete an interim 6-month visit with cognitive testing and suPAR serology. At a 12-month research clinic visit, participants will repeat cognitive testing, brain MRI, and suPAR serology. All participant encounters will provide the opportunity to gather interim clinical data such as new medical diagnoses or repeat hospitalizations.

Study Type

Observational

Enrollment (Estimated)

118

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Recruiting
        • Rush University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rajeev Garg, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients admitted to Rush University Medical Center with an intracerebral hemorrhage.

Description

Inclusion Criteria:

  • Primary Intracerebral Hemorrhage
  • Age ≥ 18 and < 80 years

Exclusion Criteria:

  • ICH score > 2
  • Pre-existing dementia
  • Prior history of stroke
  • Neurosurgical evacuation of hematoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Cognition
Time Frame: From date of randomization and assessed throughout the during hospitalization for qualifying ICH event up to 12 months
Assessed via the the Late Onset Alzheimer's Disease Family Study Cognitive Battery
From date of randomization and assessed throughout the during hospitalization for qualifying ICH event up to 12 months
Global Cognition
Time Frame: 3 months after hospitalization
Assessed via the the Late Onset Alzheimer's Disease Family Study Cognitive Battery
3 months after hospitalization
Global Cognition
Time Frame: 6 months after hospitalization
Assessed via the the Late Onset Alzheimer's Disease Family Study Cognitive Battery
6 months after hospitalization
Global Cognition
Time Frame: 12 months after hospitalization
Assessed via the the Late Onset Alzheimer's Disease Family Study Cognitive Battery
12 months after hospitalization
Absolute volumetric change in White Matter Hyperintensity (WMH)
Time Frame: from MRI at hospitalization to MRI at 12 months
Uses a novel imaging analysis algorithm on serial 3-Tesla brain MRI
from MRI at hospitalization to MRI at 12 months
Serum soluble urokinase-type plasminogen activator receptor (suPAR) levels
Time Frame: From date of consent and assessed during hospitalization for qualifying ICH event up to 12 months
compare SuPAR levels between the silent brain infarct (SBI) positive and the SBI negative groups
From date of consent and assessed during hospitalization for qualifying ICH event up to 12 months
Serum soluble urokinase-type plasminogen activator receptor (suPAR) levels
Time Frame: 3 months after hospital discharge
compare SuPAR levels between the silent brain infarct (SBI) positive and the SBI negative
3 months after hospital discharge
Serum soluble urokinase-type plasminogen activator receptor (suPAR) levels
Time Frame: 6 months after hospital discharge
compare SuPAR levels between the silent brain infarct (SBI) positive and the SBI negative
6 months after hospital discharge
Serum soluble urokinase-type plasminogen activator receptor (suPAR) levels
Time Frame: 12 months after hospital discharge
compare SuPAR levels between the silent brain infarct (SBI) positive and the SBI negative
12 months after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Rajeev Garg, MD, Rush University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2025

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

January 15, 2025

First Submitted That Met QC Criteria

February 17, 2025

First Posted (Actual)

February 20, 2025

Study Record Updates

Last Update Posted (Actual)

August 8, 2025

Last Update Submitted That Met QC Criteria

August 6, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23022401
  • 1R01NS135614-01A1 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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