Rush University Medical Center
Chicago, Illinois, 60614, United States
Location status: Recruiting
Location contact
Amanda Sremac, BS
CONTACT
Rajeev Garg, MD
CONTACT
Rajeev Garg, MD
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT06836141
Biomarkers for Cognitive Decline in Intracerebral Hemorrhage
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
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Primary Intracerebral Hemorrhage
- Age ≥ 18 and < 80 years
Exclusion criteria
- Pre-existing dementia
Treatment and study plan
MRI
Diagnostic TestMRI during hospitalization and at 12 months post sICH
Blood draw
Diagnostic TestWill occur during hospitalization and at 3, 6 and 12 months post sICH
Cognitive test
Diagnostic TestCognitive testing will occur during hospitalization and at 3, 6 and 12 months post sICH
Primary outcomes
-
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
-
Global Cognition
Time frame: 3 months after hospitalization
Assessed via the the Late Onset Alzheimer's Disease Family Study Cognitive Battery
-
Global Cognition
Time frame: 6 months after hospitalization
Assessed via the the Late Onset Alzheimer's Disease Family Study Cognitive Battery
-
Global Cognition
Time frame: 12 months after hospitalization
Assessed via the the Late Onset Alzheimer's Disease Family Study Cognitive Battery
-
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
-
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
-
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
-
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
-
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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Rush University Medical Center
Other
Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
Registry information
Official study title
Silent Brain Infarcts in Spontaneous Intracerebral Hemorrhage as a Prognostic Biomarker for Vascular Contributions to Cognitive Impairment and Dementia (VCID)
Important dates
- Study start
- 2025
- Primary completion
- 2029
- Study completion
- 2029
- First posted
- Feb 20, 2025
- Registry last updated
- Jul 13, 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.
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