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Perfusion Imaging Score to Predict Delayed Cerebral Ischemia

Perfusion Imaging Score to Predict Delayed Cerebral Ischemia

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07030985
Enrollment
55
Registered
2025-06-22
Start date
2025-09-30
Completion date
2026-09-30
Last updated
2025-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysmal Subarachnoid Hemorrhage, Cerebral Ischemia

Keywords

computed tomography perfusion, brain perfusion, early detection, prediction

Brief 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.

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.

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.

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of Delayed Cerebral Ischemia (DCI)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

MeasureTime frameDescription
Modified Rankin Scale (mRS)12 months post-aSAHMeasurement 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.
Health-Related Quality of Life (HRQoL, SF-36)12 months post-aSAHHRQoL will be reported as standardized z-scores, with higher scores indicating better performance.
Global Mental Status - Montreal Cognitive Assessment (MoCA)12 months post-aSAHScreens 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).
Executive Functioning - Wisconsin Card Sorting Test (WCST)12 months post-aSAHMeasures 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).
Correlation Between Baseline Perfusion Parameters and 12-Month Neurological Outcome12 months post-aSAHAssessment 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.
Language - Boston Naming Test (BNT)12 months post-aSAHEvaluates confrontational word retrieval and naming ability. Scores are standardized using age norms. Favorable outcome: z-score ≥ -1.0, unfavorable outcome: z-score \< -1.0
Verbal Fluency - FAS Test12 months post-aSAHTests 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
Memory - Hopkins Verbal Learning Test-Revised (HVLT-R)12 months post-aSAHAssesses 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
Composite Neuropsychological Test Scores12 months post-aSAHAnalysis 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.
Processing Speed - Symbol Digit Modalities Test (SDMT)12 months post-aSAHAssesses 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

Contacts

Primary ContactAnna Maria Bombardieri, MD, PhD
abomba@stanford.edu(650) 723-6412
Backup ContactKsenia Kasimova, MD
kasimova@stanford.edu6507889458

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026