Perfusion Imaging Score to Predict Delayed Cerebral Ischemia

NCT ID: NCT07030985

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-09-30

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.

Conditions

Aneurysmal Subarachnoid Hemorrhage; Cerebral Ischemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CTP scan

Intervention Type: RADIATION

Patients 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

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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.

Intervention Type: RADIATION

Neurological and neuropsychological testing

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Anna Maria Bombardieri

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Anna Maria Bombardieri, MD, PhD

Role: CONTACT

abomba@stanford.edu

(650) 723-6412

Ksenia Kasimova, MD

Role: CONTACT

kasimova@stanford.edu

6507889458

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Other Identifiers

81412

Identifier Type: -

Identifier Source: org_study_id