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临床试验/NCT07030985
NCT07030985尚未招募不适用

Perfusion Imaging Score to Predict Delayed Cerebral Ischemia

Stanford University0 个研究点目标入组 55 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
55
主要终点
Occurrence of Delayed Cerebral Ischemia (DCI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years with a diagnosis of aSAH

排除标准

  • 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

结局指标

主要结局

Occurrence of Delayed Cerebral Ischemia (DCI)

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Maria Bombardieri

Clinical Associate Professor

Stanford University

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