Perfusion Imaging Score to Predict Delayed Cerebral Ischemia

Обзор

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.

Подробное описание

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.

Вмешательства

• Лучевая терапия CTP scan
  Patients with diagnosed aSAH and no evidence of early radiologic vasospasm will receive a CTP scan within 48 hours of aSAH symptom onset.
• Диагностический тест Neurological and neuropsychological testing
  All enrolled patients will receive neurological and neuropsychological assessment at 12 months after aSAH.

Первичные конечные точки

• Occurrence of Delayed Cerebral Ischemia (DCI) [Срок оценки: During hospitalization (within 14 days of aneurysmal subarachnoid hemorrhage (aSAH))]

Вторичные конечные точки (10)

• Correlation Between Baseline Perfusion Parameters and 12-Month Neurological Outcome [Срок оценки: 12 months post-aSAH]
• Modified Rankin Scale (mRS) [Срок оценки: 12 months post-aSAH]
• Health-Related Quality of Life (HRQoL, SF-36) [Срок оценки: 12 months post-aSAH]
• Global Mental Status - Montreal Cognitive Assessment (MoCA) [Срок оценки: 12 months post-aSAH]
• Executive Functioning - Wisconsin Card Sorting Test (WCST) [Срок оценки: 12 months post-aSAH]
• Processing Speed - Symbol Digit Modalities Test (SDMT) [Срок оценки: 12 months post-aSAH]
• Language - Boston Naming Test (BNT) [Срок оценки: 12 months post-aSAH]
• Verbal Fluency - FAS Test [Срок оценки: 12 months post-aSAH]
• Memory - Hopkins Verbal Learning Test-Revised (HVLT-R) [Срок оценки: 12 months post-aSAH]
• Composite Neuropsychological Test Scores [Срок оценки: 12 months post-aSAH]

Критерии участия

Критерии включения

• Age >18 years with a diagnosis of aSAH

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Dodd WS, Laurent D, Dumont AS, Hasan DM, Jabbour PM, Starke RM, Hosaka K, Polifka AJ, Hoh BL, Chalouhi N. Pathophysiology of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage: A Review. J Am Heart Assoc. 2021 Aug 3;10(15):e021845. doi: 10.1161/JAHA.121.021845. Epub 2021 Jul 30. PMID 34325514
• Macdonald RL. Delayed neurological deterioration after subarachnoid haemorrhage. Nat Rev Neurol. 2014 Jan;10(1):44-58. doi: 10.1038/nrneurol.2013.246. Epub 2013 Dec 10. PMID 24323051
• Rowland MJ, Hadjipavlou G, Kelly M, Westbrook J, Pattinson KT. Delayed cerebral ischaemia after subarachnoid haemorrhage: looking beyond vasospasm. Br J Anaesth. 2012 Sep;109(3):315-29. doi: 10.1093/bja/aes264. PMID 22879655
• Baumgartner RW. Transcranial color duplex sonography in cerebrovascular disease: a systematic review. Cerebrovasc Dis. 2003;16(1):4-13. doi: 10.1159/000070108. PMID 12766355
• Nguyen AM, Williamson CA, Pandey AS, Sheehan KM, Rajajee V. Screening Computed Tomography Angiography to Identify Patients at Low Risk for Delayed Cerebral Ischemia Following Aneurysmal Subarachnoid Hemorrhage. Front Neurol. 2021 Nov 12;12:740241. doi: 10.3389/fneur.2021.740241. eCollection 2021. PMID 34867722
• Mir DI, Gupta A, Dunning A, Puchi L, Robinson CL, Epstein HA, Sanelli PC. CT perfusion for detection of delayed cerebral ischemia in aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis. AJNR Am J Neuroradiol. 2014 May;35(5):866-71. doi: 10.3174/ajnr.A3787. Epub 2013 Dec 5. PMID 24309123
• Starnoni D, Maduri R, Hajdu SD, Pierzchala K, Giammattei L, Rocca A, Grosfilley SB, Saliou G, Messerer M, Daniel RT. Early Perfusion Computed Tomography Scan for Prediction of Vasospasm and Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage. World Neurosurg. 2019 Oct;130:e743-e752. doi: 10.1016/j.wneu.2019.06.213. Epub 2019 Jul 5. PMID 31284055
• Bashir A, Andresen M, Bartek J Jr, Cortsen M, Eskesen V, Wagner A. Intra-arterial nimodipine for cerebral vasospasm after subarachnoid haemorrhage: Influence on clinical course and predictors of clinical outcome. Neuroradiol J. 2016 Feb;29(1):72-81. doi: 10.1177/1971400915626429. Epub 2016 Jan 29. PMID 26825134

Идентификаторы

NCT: NCT07030985 · 81412

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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