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NCT Number: NCT07030985

Perfusion Imaging Score to Predict Delayed Cerebral Ischemia

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.

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Key information

Conditions

Aneurysmal Subarachnoid Hemorrhage Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Ischemia Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 years with a diagnosis of aSAH

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

Treatment and study plan

CTP scan

Radiation

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 testing

Diagnostic Test

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

Primary outcomes

  1. Occurrence of Delayed Cerebral Ischemia (DCI)

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

    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.

Secondary outcomes

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

    Time frame: 12 months post-aSAH

    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.

  2. Modified Rankin Scale (mRS)

    Time frame: 12 months post-aSAH

    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.

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

    Time frame: 12 months post-aSAH

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

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

    Time frame: 12 months post-aSAH

    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).

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

    Time frame: 12 months post-aSAH

    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).

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

    Time frame: 12 months post-aSAH

    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

  7. Language - Boston Naming Test (BNT)

    Time frame: 12 months post-aSAH

    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

  8. Verbal Fluency - FAS Test

    Time frame: 12 months post-aSAH

    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

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

    Time frame: 12 months post-aSAH

    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

  10. Composite Neuropsychological Test Scores

    Time frame: 12 months post-aSAH

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Maria Bombardieri, MD, PhD

CONTACT

[email protected]

(650) 723-6412

Ksenia Kasimova, MD

CONTACT

[email protected]

6507889458

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2025
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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