subarachnoid hemorrhage, intracranial arterial stenosis or occlusion, including moyamoya disease Subarachnoid hemorrhage, vasospasm, moyamoya disease, hyperperfusion syndrome
Conditions
Interventions
Sonazoid contrast agent for echography is administered intravenously to perform real-time evaluation of cerebral perfusion, including intracranial vascular morphology and cerebral blood flow.
Sponsors
Saito Ryuta
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria. (1) The patient must be 18 years of age or older. (2) The patient or their legal representative has received sufficient explanation regarding the purpose, content, risks, and data processing of the study and has provided written consent. (3) The patient has been diagnosed with subarachnoid hemorrhage, moyamoya disease, or other intracranial vascular occlusive disease. (4) The patient is hospitalized and, based on the attending physician's judgment, is deemed suitable for CTP to evaluate cerebral perfusion.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following exclusion criteria shall not be enrolled in this study. (1) Pregnant or lactating women (2) Individuals with known contraindications or hypersensitivity to the ultrasound contrast agent Sonazoid (including hypersensitivity to excipients such as sulfur hexafluoride microbubbles or polyethylene glycol (PEG)) (3) Individuals with allergies to eggs or egg products (4) Individuals with right-to-left shunts (e.g., due to cardiac anomalies) (5) Individuals with unstable hemodynamics or respiratory status, rendering transport to the CTP device contraindicated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimation of the Intraclass Correlation Coefficient (ICC) and its 95% Confidence Interval between brain perfusion parameters (TTP, MTT) obtained from the SYLVER device and those obtained from CTP | — |
Secondary
| Measure | Time frame |
|---|---|
| - Evaluation of fixed and proportional biases between SYLVER device and CTP measurements (Bland-Altman plot). - Agreement between SYLVER device-detected perfusion deficits/hyperperfusion and CTP-diagnosed findings. - Evaluation of consistency between SYLVER device microvascular imaging (MVI) visualization of vascular structures and CTA images. - Correlation between blood flow velocity calculated from SYLVER device parameters and blood flow velocity obtained from TCD. - Collection and analysis of the incidence of adverse events (AE), serious adverse events (SAE), and device malfunctions (DD) associated with SYLVER device use. | — |
Contacts
Public ContactShinsuke Muraoka
Nagoya University Graduate School of Medicine
Outcome results
None listed