Perfusion Imaging Score to Predict Delayed Cerebral Ischemia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18 years with a diagnosis of aSAH
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
CTP scan
RadiationPatients 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 testAll enrolled patients will receive neurological and neuropsychological assessment at 12 months after aSAH.
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: Patients diagnosed with aSAHExperimental treatment 2 interventions
Trial outcomes
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-aSAH2
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-aSAH3
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-aSAH4
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-aSAHLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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