Perfusion Imaging Score to Predict Delayed Cerebral Ischemia

Not Applicable

Not yet recruiting

• Conditions: Aneurysmal Subarachnoid Hemorrhage; Cerebral Ischemia

• Registration Number: NCT07030985
• Lead Sponsor: Stanford University

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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-12
• Study First Submitted QC: 2025-06-12
• Study First Posted: 2025-06-22
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-26
• Study Start: 2025-09-01
• Primary Completion: 2026-09
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Correlation Between Baseline Perfusion Parameters and 12-Month Neurological Outcome	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.
Modified Rankin Scale (mRS)	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.
Health-Related Quality of Life (HRQoL, SF-36)	12 months post-aSAH	HRQoL will be reported as standardized z-scores, with higher scores indicating better performance.
Global Mental Status - Montreal Cognitive Assessment (MoCA)	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).
Executive Functioning - Wisconsin Card Sorting Test (WCST)	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).
Processing Speed - Symbol Digit Modalities Test (SDMT)	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
Language - Boston Naming Test (BNT)	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
Memory - Hopkins Verbal Learning Test-Revised (HVLT-R)	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
Verbal Fluency - FAS Test	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
Composite Neuropsychological Test Scores	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.