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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NS135614-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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
Participants will undergo
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Diagnostic Test | MRI during hospitalization and at 12 months post sICH | ||
| Blood Draw | Diagnostic Test | Will occur during hospitalization and at 3, 6 and 12 months post sICH | ||
| Cognitive Test | Diagnostic Test | Cognitive testing will occur during hospitalization and at 3, 6 and 12 months post sICH |
| Measure | Description | Time Frame |
|---|---|---|
| Global Cognition | 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 | Assessed via the the Late Onset Alzheimer's Disease Family Study Cognitive Battery | 3 months after hospitalization |
| Global Cognition | Assessed via the the Late Onset Alzheimer's Disease Family Study Cognitive Battery | 6 months after hospitalization |
| Global Cognition | 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) | 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 | 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 | compare SuPAR levels between the silent brain infarct (SBI) positive and the SBI negative |
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Inclusion Criteria:
Exclusion Criteria:
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All patients admitted to Rush University Medical Center with an intracerebral hemorrhage.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda Sremac, BS | Contact | 312-942-0593 | Amanda_C_Sremac@rush.edu | |
| Rajeev Garg, MD | Contact | Rajeev_Garg@rush.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rajeev Garg, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60614 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35579034 | Background | Greenberg SM, Ziai WC, Cordonnier C, Dowlatshahi D, Francis B, Goldstein JN, Hemphill JC 3rd, Johnson R, Keigher KM, Mack WJ, Mocco J, Newton EJ, Ruff IM, Sansing LH, Schulman S, Selim MH, Sheth KN, Sprigg N, Sunnerhagen KS; American Heart Association/American Stroke Association. 2022 Guideline for the Management of Patients With Spontaneous Intracerebral Hemorrhage: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2022 Jul;53(7):e282-e361. doi: 10.1161/STR.0000000000000407. Epub 2022 May 17. No abstract available. | |
| 32078490 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 17, 2024 | Jan 10, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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blood
| 3 months after hospital discharge |
| Serum soluble urokinase-type plasminogen activator receptor (suPAR) levels | 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 | compare SuPAR levels between the silent brain infarct (SBI) positive and the SBI negative | 12 months after hospital discharge |
| Background |
| Hemorrhagic Stroke Academia Industry (HEADS) Roundtable Participants; Second HEADS Roundtable Participants. Recommendations for Clinical Trials in ICH: The Second Hemorrhagic Stroke Academia Industry Roundtable. Stroke. 2020 Apr;51(4):1333-1338. doi: 10.1161/STROKEAHA.119.027882. Epub 2020 Feb 10. No abstract available. |
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| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |