Biomarkers for Cognitive Decline in Intracerebral Hemorrhage
NCT ID: NCT06836141
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
118 participants
OBSERVATIONAL
2025-08-02
2029-08-01
Brief Summary
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* 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
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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MRI
MRI during hospitalization and at 12 months post sICH
Blood Draw
Will occur during hospitalization and at 3, 6 and 12 months post sICH
Cognitive Test
Cognitive testing will occur during hospitalization and at 3, 6 and 12 months post sICH
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 and \< 80 years
Exclusion Criteria
* Pre-existing dementia
* Prior history of stroke
* Neurosurgical evacuation of hematoma
18 Years
80 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Rush University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Rajeev Garg, MD
Role: PRINCIPAL_INVESTIGATOR
Rush University Medical Center
Locations
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Rush University Medical Center
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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23022401
Identifier Type: -
Identifier Source: org_study_id
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