NCT07324421

Comparison of Ultrasound Cerebral Perfusion Imaging With Routine Perfusion CT

Prospective Monocentric Study Comparing Cerebral Perfusion Parameters From an ULtrasonic Imaging System With Measures Provided by Clinical Routine Perfusion CT

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Resolve Stroke · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary goal of neurocritical care is to prevent secondary brain injury, which worsens neurological outcomes. Because clinical monitoring is often insufficient due to the patient's condition and medical treatments, multimodal monitoring using biophysical, electrophysiological, and imaging data is essential. In patients with subarachnoid hemorrhage (SAH), the most frequent and severe complication is delayed cerebral ischemia, often linked to arterial vasospasm and potentially leading to infarction. Early diagnosis combines transcranial Doppler (TCD), sensitive to vasospasm, with perfusion CT (CTP), which measures cerebral perfusion; this approach guides therapy and improves prognosis. Ultrasound, especially when enhanced with contrast agents (CEUS), allows non-invasive, bedside, repeated visualization of cerebral blood flow and perfusion-even through the skull. Agents like SonoVue® help quantify perfusion using time-intensity curves. The study aims to assess whether cerebral perfusion measurements from the SYLVER device are equivalent to those from CTP in ICU or CCU patients.

Conditions

• Neuro ICU
• Sub Arachnoid Hemorrhage
• Neurological Complication
• Cerebral Ischemia
• Brain Injuries, Vascular

Interventions

Type	Name	Description
DEVICE	Ultrasound contrast agent (Contrast-enhanced ultrasound)	The V0 (screening) visit occurs during ICU/CCU hospitalization, with routine clinical exam, eligibility check, and informed consent from the patient or a relative. Assessments include demographics, medical history, clinical exam, treatments, cerebral perfusion by CTP, anatomy by CTA, SYLVER perfusion/anatomy, TCD velocities, and AE/device deficiency recording. V0 lasts \~30 min. V1 (Day 1 or possibly Day 0 in urgent cases) includes clinical exam, TCD, CTP/CTA, and SYLVER use (\~30 min extra; total \~1h30). Imaging order is flexible but times are logged. V2-V5 occur if, by Day 21, ICU/CCU stay continues and care requires further CTP for suspected hypoperfusion (max once/day).

Timeline

• Start date: 2025-10-25
• Primary completion: 2026-06-04
• Completion: 2026-08-15
• First posted: 2026-01-07
• Last updated: 2026-01-07

Locations

1 site across 1 country: France