Perfusion Imaging Score to Predict Delayed Cerebral Ischemia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Stanford University
- Enrollment
- 55
- Primary Endpoint
- Occurrence of Delayed Cerebral Ischemia (DCI)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Patients diagnosed with aSAH
Patients will undergo the following study procedures:
- a CTP scan after aSAH diagnosis
- neurological and the neuropsychological tests at 12-month after the hemorrhage.
Intervention: CTP scan (Radiation)
Patients diagnosed with aSAH
Patients will undergo the following study procedures:
- a CTP scan after aSAH diagnosis
- neurological and the neuropsychological tests at 12-month after the hemorrhage.
Intervention: Neurological and neuropsychological testing (Diagnostic Test)
Outcomes
Primary Outcomes
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
- Correlation Between Baseline Perfusion Parameters and 12-Month Neurological Outcome(12 months post-aSAH)
- Modified Rankin Scale (mRS)(12 months post-aSAH)
- Health-Related Quality of Life (HRQoL, SF-36)(12 months post-aSAH)
- Global Mental Status - Montreal Cognitive Assessment (MoCA)(12 months post-aSAH)
- Executive Functioning - Wisconsin Card Sorting Test (WCST)(12 months post-aSAH)
- Processing Speed - Symbol Digit Modalities Test (SDMT)(12 months post-aSAH)
- Language - Boston Naming Test (BNT)(12 months post-aSAH)
- Memory - Hopkins Verbal Learning Test-Revised (HVLT-R)(12 months post-aSAH)
- Verbal Fluency - FAS Test(12 months post-aSAH)
- Composite Neuropsychological Test Scores(12 months post-aSAH)
Investigators
Anna Maria Bombardieri
Clinical Associate Professor
Stanford University