Recruiting

Observational Study

Sponsor:

Rush University Medical Center

Code:

NCT06836141

Conditions

Primary Intracerebral Hemorrhage

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

MRI

Blood Draw

Cognitive Test

Study Details

Brief summary:

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

Conditions

Primary Intracerebral Hemorrhage

Study ID

NCT06836141

Start date

Aug 2, 2025

Status verified date

Jul, 2026

Completion date

Aug 1, 2029

Anticipated

Primary completion date

Aug 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Pre-existing dementia

Study Design

Enrollment

118 participants

Anticipated

Interventions and Outcome Measures

Interventions

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

Primary outcome measure

  • Global Cognition [ Time Frame: 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 ]
  • Global Cognition [ Time Frame: 6 months after hospitalization ]
  • Global Cognition [ Time Frame: 12 months after hospitalization ]
  • Absolute volumetric change in White Matter Hyperintensity (WMH) [ Time Frame: 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 ]
  • Serum soluble urokinase-type plasminogen activator receptor (suPAR) levels [ Time Frame: 3 months after hospital discharge ]
  • Serum soluble urokinase-type plasminogen activator receptor (suPAR) levels [ Time Frame: 6 months after hospital discharge ]
  • Serum soluble urokinase-type plasminogen activator receptor (suPAR) levels [ Time Frame: 12 months after hospital discharge ]

Central Contacts and Locations

Central contacts

Amanda Sremac, BS

312-942-0593Amanda_C_Sremac@rush.edu

Rajeev Garg, MD

Rajeev_Garg@rush.edu

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60614

Contacts

Rajeev Garg, MD

Rajeev_Garg@rush.edu

Amanda Sremac, BS

312-942-0593Amanda_C_Sremac@rush.edu

Principal Investigator:

Rajeev Garg, MD

More Information

Sponsor

Rush University Medical Center

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2026-07-13.