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AzTrials

Aneurysmal Subarachnoid HemorrhageNCT07030985

Perfusion Imaging Score to Predict Delayed Cerebral Ischemia

A study testing CTP scan and Neurological and neuropsychological testing in people with Aneurysmal Subarachnoid Hemorrhage and Cerebral Ischemia, run by Stanford University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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

Who is it for?
Ages 18 years and older
What is being tested?
CTP scan and Neurological and neuropsychological testing
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
No sites listed yet
Study dates
Sep 2025to Sep 2026
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >18 years with a diagnosis of aSAH

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Anna Maria Bombardieri, MD, PhD contact

(650) 723-6412

abomba@stanford.edu

Ksenia Kasimova, MD contact

6507889458

kasimova@stanford.edu

About this study

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.

Being tested
CTP scan, Neurological and neuropsychological testing
Keywords
computed tomography perfusion, brain perfusion, early detection, prediction
Medical subject headings
Subarachnoid Hemorrhage, Brain Ischemia

What participants receive

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

  • CTP scanRadiation

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

  • Neurological and neuropsychological testingDiagnostic test

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

Study groups in NCT07030985
Study groupRoleWhat they receive
Patients diagnosed with aSAHExperimentalPatients will undergo the following study procedures: * a CTP scan after aSAH diagnosis * neurological and the neuropsychological tests at 12-month after the hemorrhage.
Receives: Radiation: CTP scan; Diagnostic Test: Neurological and neuropsychological testing

What is being measured

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

  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.

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

Secondary outcomes (10)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: 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).

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: 12 months post-aSAH

Timeline

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

  1. First posted22 Jun 2025
  2. Study startSep 2025 (estimated)
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07030985
Sponsor's protocol ID
81412
Status last verified
Jun 2025
First submitted
12 Jun 2025
Last updated
26 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing CTP scan and Neurological and neuropsychological testing in people with Aneurysmal Subarachnoid Hemorrhage and Cerebral Ischemia, run by Stanford University.

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 1 inclusion and 4 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: opening soon, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

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 Anna Maria Bombardieri, MD, PhD ((650) 723-6412, abomba@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Delayed Cerebral Ischemia (DCI) (time frame: During hospitalization (within 14 days of aneurysmal subarachnoid hemorrhage (aSAH))). 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 NCT07030985, which also lists 10 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 26 Jun 2025.

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