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Primary Intracerebral HemorrhageNCT06836141

Biomarkers for Cognitive Decline in Intracerebral Hemorrhage

An observational study of Primary Intracerebral Hemorrhage, run by Rush University Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Primary Intracerebral Hemorrhage
What is being tested?
MRI, Blood Draw and Cognitive Test
How many people
118 participants
Where
1 siteUnited States
Study dates
2 Aug 2025to 1 Aug 2029
How long will I take part?
12 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Pre-existing dementia

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Amanda Sremac, BS contact

312-942-0593

Amanda_C_Sremac@rush.edu

Rajeev Garg, MD contact

Rajeev_Garg@rush.edu

United States1 site, 1 recruiting
  • Rush University Medical Center

    Chicago, Illinois, 60614

    Rajeev Garg, MD, Rajeev_Garg@rush.edu

    Amanda Sremac, BS, 312-942-0593, Amanda_C_Sremac@rush.edu

    Recruiting

Other trials in United States

About this study

Official title: 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
Read more

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
Read the 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.

Being tested
MRI, Blood Draw, Cognitive Test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRIDiagnostic test

    MRI during hospitalization and at 12 months post sICH

  • Blood DrawDiagnostic test

    Will occur during hospitalization and at 3, 6 and 12 months post sICH

  • Cognitive TestDiagnostic test

    Cognitive testing will occur during hospitalization and at 3, 6 and 12 months post sICH

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global Cognition

    Assessed via the the Late Onset Alzheimer's Disease Family Study Cognitive Battery

    Measured: From date of randomization and assessed throughout the during hospitalization for qualifying ICH event up to 12 months

  2. Global Cognition

    Assessed via the the Late Onset Alzheimer's Disease Family Study Cognitive Battery

    Measured: 3 months after hospitalization

  3. Global Cognition

    Assessed via the the Late Onset Alzheimer's Disease Family Study Cognitive Battery

    Measured: 6 months after hospitalization

  4. Global Cognition

    Assessed via the the Late Onset Alzheimer's Disease Family Study Cognitive Battery

    Measured: 12 months after hospitalization

  5. Absolute volumetric change in White Matter Hyperintensity (WMH)

    Uses a novel imaging analysis algorithm on serial 3-Tesla brain MRI

    Measured: from MRI at hospitalization to MRI at 12 months

  6. Serum soluble urokinase-type plasminogen activator receptor (suPAR) levels

    compare SuPAR levels between the silent brain infarct (SBI) positive and the SBI negative groups

    Measured: From date of consent and assessed during hospitalization for qualifying ICH event up to 12 months

  7. Serum soluble urokinase-type plasminogen activator receptor (suPAR) levels

    compare SuPAR levels between the silent brain infarct (SBI) positive and the SBI negative

    Measured: 3 months after hospital discharge

  8. Serum soluble urokinase-type plasminogen activator receptor (suPAR) levels

    compare SuPAR levels between the silent brain infarct (SBI) positive and the SBI negative

    Measured: 6 months after hospital discharge

  9. Serum soluble urokinase-type plasminogen activator receptor (suPAR) levels

    compare SuPAR levels between the silent brain infarct (SBI) positive and the SBI negative

    Measured: 12 months after hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2025
  2. Study start2 Aug 2025
  3. Primary completion1 Aug 2029 (estimated)
  4. Study completion1 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
118 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06836141
Sponsor's protocol ID
23022401
Other IDs
1R01NS135614-01A1
Status last verified
Jul 2026
First submitted
15 Jan 2025
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35579034
  • 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.

    PubMed 32078490
  • Hwang DY, Kim KS, Muehlschlegel S, Wartenberg KE, Rajajee V, Alexander SA, Busl KM, Creutzfeldt CJ, Fontaine GV, Hocker SE, Madzar D, Mahanes D, Mainali S, Sakowitz OW, Varelas PN, Weimar C, Westermaier T, Meixensberger J. Guidelines for Neuroprognostication in Critically Ill Adults with Intracerebral Hemorrhage. Neurocrit Care. 2024 Apr;40(2):395-414. doi: 10.1007/s12028-023-01854-7. Epub 2023 Nov 3.

    PubMed 37923968
  • Smith HW, Marshall CJ. Regulation of cell signalling by uPAR. Nat Rev Mol Cell Biol. 2010 Jan;11(1):23-36. doi: 10.1038/nrm2821.

    PubMed 20027185
  • Nikorowitsch J, Borchardt T, Appelbaum S, Ojeda F, Lackner KJ, Schnabel RB, Blankenberg S, Zeller T, Karakas M. Cardio-Renal Biomarker Soluble Urokinase-Type Plasminogen Activator Receptor Is Associated With Cardiovascular Death and Myocardial Infarction in Patients With Coronary Artery Disease Independent of Troponin, C-Reactive Protein, and Renal Function. J Am Heart Assoc. 2020 Apr 21;9(8):e015452. doi: 10.1161/JAHA.119.015452. Epub 2020 Apr 17.

    PubMed 32299288
  • Wilson RS, Yu L, Lamar M, Schneider JA, Boyle PA, Bennett DA. Education and cognitive reserve in old age. Neurology. 2019 Mar 5;92(10):e1041-e1050. doi: 10.1212/WNL.0000000000007036. Epub 2019 Feb 6.

    PubMed 30728309
  • Garg RK, Khan J, Dawe RJ, Conners J, John S, Prabhakaran S, Kocak M, Bhabad S, Simpson SL, Ouyang B, Jhaveri M, Bleck TP. The Influence of Diffusion Weighted Imaging Lesions on Outcomes in Patients with Acute Spontaneous Intracerebral Hemorrhage. Neurocrit Care. 2020 Oct;33(2):552-564. doi: 10.1007/s12028-020-00933-3.

    PubMed 32072457
  • Grosu S, Rospleszcz S, Hartmann F, Habes M, Bamberg F, Schlett CL, Galie F, Lorbeer R, Auweter S, Selder S, Buelow R, Heier M, Rathmann W, Mueller-Peltzer K, Ladwig KH, Grabe HJ, Peters A, Ertl-Wagner BB, Stoecklein S. Associated factors of white matter hyperintensity volume: a machine-learning approach. Sci Rep. 2021 Jan 27;11(1):2325. doi: 10.1038/s41598-021-81883-4.

    PubMed 33504924
  • Greenberg SM, O'Donnell HC, Schaefer PW, Kraft E. MRI detection of new hemorrhages: potential marker of progression in cerebral amyloid angiopathy. Neurology. 1999 Sep 22;53(5):1135-8. doi: 10.1212/wnl.53.5.1135.

    PubMed 10496283
  • Maclullich AM, Wardlaw JM, Ferguson KJ, Starr JM, Seckl JR, Deary IJ. Enlarged perivascular spaces are associated with cognitive function in healthy elderly men. J Neurol Neurosurg Psychiatry. 2004 Nov;75(11):1519-23. doi: 10.1136/jnnp.2003.030858.

    PubMed 15489380
  • Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006.

    PubMed 19414839
  • Chew-Harris J, Appleby S, Richards AM, Troughton RW, Pemberton CJ. Analytical, biochemical and clearance considerations of soluble urokinase plasminogen activator receptor (suPAR) in healthy individuals. Clin Biochem. 2019 Jul;69:36-44. doi: 10.1016/j.clinbiochem.2019.05.010. Epub 2019 May 23.

    PubMed 31129182
  • Eugen-Olsen J, Ladelund S, Sorensen LT. Plasma suPAR is lowered by smoking cessation: a randomized controlled study. Eur J Clin Invest. 2016 Apr;46(4):305-11. doi: 10.1111/eci.12593. Epub 2016 Feb 19.

    PubMed 26799247
  • Haupt TH, Kallemose T, Ladelund S, Rasmussen LJ, Thorball CW, Andersen O, Pisinger C, Eugen-Olsen J. Risk factors associated with serum levels of the inflammatory biomarker soluble urokinase plasminogen activator receptor in a general population. Biomark Insights. 2014 Dec 16;9:91-100. doi: 10.4137/BMI.S19876. eCollection 2014.

    PubMed 25574132
  • Mehta A, Desai SR, Ko YA, Liu C, Dhindsa DS, Nayak A, Hooda A, Martini MA, Ejaz K, Sperling LS, Reiser J, Hayek SS, Quyyumi AA. Sex Differences in Circulating Soluble Urokinase-Type Plasminogen Activator Receptor (suPAR) Levels and Adverse Outcomes in Coronary Artery Disease. J Am Heart Assoc. 2020 Mar 3;9(5):e015457. doi: 10.1161/JAHA.119.015457. Epub 2020 Feb 22.

    PubMed 32089048

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Intracerebral Hemorrhage, run by Rush University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amanda Sremac, BS (312-942-0593, Amanda_C_Sremac@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06836141, which also lists 52 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

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