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Not yet recruitingNCT07030985Updated Jun 26, 2025

Perfusion Imaging Score to Predict Delayed Cerebral Ischemia

An interventional study of CTP scan and Neurological and neuropsychological testing in Aneurysmal Subarachnoid Hemorrhage and Cerebral Ischemia, sponsored by Stanford University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-26.

Sponsored by Stanford University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Aneurysmal subarachnoid hemorrhage (aSAH) is a significant public health concern, annually affecting over 30,000 Americans and ranking among the leading causes of stroke-related life-years lost in individuals aged 65 and younger. Delayed cerebral ischemia (DCI), occurring in 20% to 40% of aSAH survivors, is a major contributor to brain injury and disability. Timely recognition of DCI is crucial for improving neurological outcomes and preventing irreversible cerebral infarction. However, current methods have substantial limitations, hindering early and reliable detection. This proposal seeks to address these challenges through determining the ability of perfusion imaging to predict DCI and correlate with neurological and neuropsychological outcomes.

Read the detailed description

Patients with a diagnosis of aSAH and no early radiologic vasospasm on admission demonstrated by DSA will receive a CT Perfusion (CTP) scan within 48 hours of aSAH symptom onset. The researchers seek to determine whether these baseline scans will identify perfusion parameters predictive of DCI. At 12-months mark post-hemorrhage, neurological and neuropsychological tests will be conducted to determine whether perfusion imaging correlates with neurological and neuropsychological outcomes.

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Conditions studied

  • Aneurysmal Subarachnoid Hemorrhage
  • Cerebral Ischemia

Keywords

  • computed tomography perfusion
  • brain perfusion
  • early detection
  • prediction
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age >18 years with a diagnosis of aSAH

Exclusion criteria

Exclusion Criteria:

  • chronic kidney disease stage IV
  • pregnancy
  • allergy to iodine that precludes CTP
  • subjects with significant aphasia, blindness, or other factors that limit their participation in the cognitive assessment
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (estimated)

Study arms

  • Experimental
    Patients diagnosed with aSAH

    Patients will undergo the following study procedures: * a CTP scan after aSAH diagnosis * neurological and the neuropsychological tests at 12-month after the hemorrhage.

    Radiation: CTP scan · Diagnostic Test: Neurological and neuropsychological testing

Interventions

  • RadiationCTP scan

    Patients with diagnosed aSAH and no evidence of early radiologic vasospasm will receive a CTP scan within 48 hours of aSAH symptom onset.

  • Diagnostic testNeurological and neuropsychological testing

    All enrolled patients will receive neurological and neuropsychological assessment at 12 months after aSAH.

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What researchers measure

Primary outcomes

  1. Occurrence of Delayed Cerebral Ischemia (DCI)

    DCI will be diagnosed using the 2010 consensus definition, including new focal neurological impairments (e.g., hemiparesis, aphasia, apraxia, hemianopia, or neglect) or a decrease of ≥2 points on the Glasgow Coma Scale lasting ≥1 hour, not immediately after aneurysm treatment and not due to other identifiable causes.

    Time frame: During hospitalization (within 14 days of aneurysmal subarachnoid hemorrhage (aSAH))

Secondary outcomes

  1. Correlation Between Baseline Perfusion Parameters and 12-Month Neurological Outcome

    Assessment of whether poor baseline perfusion profile (DCI Index Score (DIS) \> 0.06) correlates with worse outcomes on neurological and neuropsychological assessments including modified Rankin Scale (mRS), 36-Item Short Form Health Survey (SF-36), and standardized cognitive test z-scores.

    Time frame: 12 months post-aSAH

  2. Modified Rankin Scale (mRS)

    Measurement of functional disability using mRS, categorized as favorable (0-3) or unfavorable (4-6), to assess long-term disability and its association with baseline perfusion.

    Time frame: 12 months post-aSAH

  3. Health-Related Quality of Life (HRQoL, SF-36)

    HRQoL will be reported as standardized z-scores, with higher scores indicating better performance.

    Time frame: 12 months post-aSAH

  4. Global Mental Status - Montreal Cognitive Assessment (MoCA)

    Screens for mild cognitive impairment across multiple cognitive domains. Raw scores range from 0 to 30. Favorable outcome: MoCA score ≥ 26, unfavorable outcome: MoCA score \< 26 (suggestive of cognitive impairment).

    Time frame: 12 months post-aSAH

  5. Executive Functioning - Wisconsin Card Sorting Test (WCST)

    Measures executive functioning, including cognitive flexibility and problem-solving. The number of categories completed and total errors will be converted to age-adjusted z-scores. Favorable outcome: z-score ≥ -1.0, unfavorable outcome: z-score \< -1.0 (indicative of cognitive impairment in executive functioning).

    Time frame: 12 months post-aSAH

  6. Processing Speed - Symbol Digit Modalities Test (SDMT)

    Assesses visual scanning, tracking, and motor speed. Raw scores are adjusted for age and converted to z-scores. Favorable outcome: z-score ≥ -1.0, unfavorable outcome: z-score \< -1.0

    Time frame: 12 months post-aSAH

  7. Language - Boston Naming Test (BNT)

    Evaluates confrontational word retrieval and naming ability. Scores are standardized using age norms. Favorable outcome: z-score ≥ -1.0, unfavorable outcome: z-score \< -1.0

    Time frame: 12 months post-aSAH

  8. Verbal Fluency - FAS Test

    Tests lexical fluency by asking participants to generate words beginning with F, A, and S in a set time period. Z-scores are calculated from age-adjusted norms. Favorable outcome: z-score ≥ -1.0, unfavorable outcome: z-score \< -1.0

    Time frame: 12 months post-aSAH

  9. Memory - Hopkins Verbal Learning Test-Revised (HVLT-R)

    Assesses verbal learning and memory, including immediate recall, delayed recall, and recognition. Performance is normed and converted into z-scores. Favorable outcome: z-score ≥ -1.0, unfavorable outcome: z-score \< -1.0

    Time frame: 12 months post-aSAH

  10. Composite Neuropsychological Test Scores

    Analysis of cognitive function via composite z-scores derived from tests across executive function, memory, language, verbal fluency, processing speed, and global cognition (e.g., MoCA, HVLT-R, Boston Naming Test). Worse outcomes are defined by lower neuropsychological z-scores.

    Time frame: 12 months post-aSAH

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Dodd WS, Laurent D, Dumont AS, Hasan DM, Jabbour PM, Starke RM, Hosaka K, Polifka AJ, Hoh BL, Chalouhi N. Pathophysiology of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage: A Review. J Am Heart Assoc. 2021 Aug 3;10(15):e021845. doi: 10.1161/JAHA.121.021845. Epub 2021 Jul 30. PubMed 34325514 ↗
  • Macdonald RL. Delayed neurological deterioration after subarachnoid haemorrhage. Nat Rev Neurol. 2014 Jan;10(1):44-58. doi: 10.1038/nrneurol.2013.246. Epub 2013 Dec 10. PubMed 24323051 ↗
  • Rowland MJ, Hadjipavlou G, Kelly M, Westbrook J, Pattinson KT. Delayed cerebral ischaemia after subarachnoid haemorrhage: looking beyond vasospasm. Br J Anaesth. 2012 Sep;109(3):315-29. doi: 10.1093/bja/aes264. PubMed 22879655 ↗
  • Baumgartner RW. Transcranial color duplex sonography in cerebrovascular disease: a systematic review. Cerebrovasc Dis. 2003;16(1):4-13. doi: 10.1159/000070108. PubMed 12766355 ↗
  • Nguyen AM, Williamson CA, Pandey AS, Sheehan KM, Rajajee V. Screening Computed Tomography Angiography to Identify Patients at Low Risk for Delayed Cerebral Ischemia Following Aneurysmal Subarachnoid Hemorrhage. Front Neurol. 2021 Nov 12;12:740241. doi: 10.3389/fneur.2021.740241. eCollection 2021. PubMed 34867722 ↗
  • Mir DI, Gupta A, Dunning A, Puchi L, Robinson CL, Epstein HA, Sanelli PC. CT perfusion for detection of delayed cerebral ischemia in aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis. AJNR Am J Neuroradiol. 2014 May;35(5):866-71. doi: 10.3174/ajnr.A3787. Epub 2013 Dec 5. PubMed 24309123 ↗
  • Starnoni D, Maduri R, Hajdu SD, Pierzchala K, Giammattei L, Rocca A, Grosfilley SB, Saliou G, Messerer M, Daniel RT. Early Perfusion Computed Tomography Scan for Prediction of Vasospasm and Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage. World Neurosurg. 2019 Oct;130:e743-e752. doi: 10.1016/j.wneu.2019.06.213. Epub 2019 Jul 5. PubMed 31284055 ↗
  • Bashir A, Andresen M, Bartek J Jr, Cortsen M, Eskesen V, Wagner A. Intra-arterial nimodipine for cerebral vasospasm after subarachnoid haemorrhage: Influence on clinical course and predictors of clinical outcome. Neuroradiol J. 2016 Feb;29(1):72-81. doi: 10.1177/1971400915626429. Epub 2016 Jan 29. PubMed 26825134 ↗
  • Dorhout Mees SM, Rinkel GJ, Feigin VL, Algra A, van den Bergh WM, Vermeulen M, van Gijn J. Calcium antagonists for aneurysmal subarachnoid haemorrhage. Cochrane Database Syst Rev. 2007 Jul 18;2007(3):CD000277. doi: 10.1002/14651858.CD000277.pub3. PubMed 17636626 ↗
  • Hosmann A, Rauscher S, Wang WT, Dodier P, Bavinzski G, Knosp E, Gruber A. Intra-Arterial Papaverine-Hydrochloride and Transluminal Balloon Angioplasty for Neurointerventional Management of Delayed-Onset Post-Aneurysmal Subarachnoid Hemorrhage Vasospasm. World Neurosurg. 2018 Nov;119:e301-e312. doi: 10.1016/j.wneu.2018.07.138. Epub 2018 Jul 24. PubMed 30053563 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT07030985
Lead sponsor
Stanford University
Responsible party
Anna Maria Bombardieri (Clinical Associate Professor, Stanford University) — Principal investigator
First posted
Jun 22, 2025
Start date
Sep 2025 (estimated)
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Jun 26, 2025

Study contacts

Anna Maria Bombardieri, MD, PhD
Contact
abomba@stanford.edu
(650) 723-6412
Ksenia Kasimova, MD
Contact
kasimova@stanford.edu
6507889458

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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