Perfusion Imaging Score to Predict Delayed Cerebral Ischemia

NCT07030985 | Not Yet Recruiting

• 1 other identifier: 81412
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aneurysmal Subarachnoid Hemorrhage; Cerebral Ischemia

Keywords

computed tomography perfusion; brain perfusion; early detection; prediction

Outcome Measures

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.

  During hospitalization (within 14 days of aneurysmal subarachnoid hemorrhage (aSAH))

Secondary Outcomes (10)

• 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

Study Arms (1)

Patients diagnosed with aSAH

EXPERIMENTAL

Patients will undergo the following study procedures: * a CTP scan after aSAH diagnosis * neurological and the neuropsychological tests at 12-month after the hemorrhage.

Radiation: CTP scan; Diagnostic Test: Neurological and neuropsychological testing

Interventions

CTP scan RADIATION

Patients with diagnosed aSAH and no evidence of early radiologic vasospasm will receive a CTP scan within 48 hours of aSAH symptom onset.

Patients diagnosed with aSAH

Neurological and neuropsychological testing DIAGNOSTIC_TEST

All enrolled patients will receive neurological and neuropsychological assessment at 12 months after aSAH.

Patients diagnosed with aSAH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years with a diagnosis of aSAH

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Dorhout Mees SM, Rinkel GJ, Feigin VL, Algra A, van den Bergh WM, Vermeulen M, van Gijn J. Calcium antagonists for aneurysmal subarachnoid haemorrhage. Cochrane Database Syst Rev. 2007 Jul 18;2007(3):CD000277. doi: 10.1002/14651858.CD000277.pub3.

  PMID: 17636626 BACKGROUND

• Hosmann A, Rauscher S, Wang WT, Dodier P, Bavinzski G, Knosp E, Gruber A. Intra-Arterial Papaverine-Hydrochloride and Transluminal Balloon Angioplasty for Neurointerventional Management of Delayed-Onset Post-Aneurysmal Subarachnoid Hemorrhage Vasospasm. World Neurosurg. 2018 Nov;119:e301-e312. doi: 10.1016/j.wneu.2018.07.138. Epub 2018 Jul 24.

  PMID: 30053563 BACKGROUND

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Brain Ischemia

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Anna Maria Bombardieri, MD, PhD

CONTACT

(650) 723-6412; abomba@stanford.edu

Ksenia Kasimova, MD

CONTACT

6507889458; kasimova@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share