3D imaging technique for detecting brain complications after a type of stroke
Pilot Study : Characterization of Early Brain Injury and Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage by Ultrasound Localization Microscopy (ULM) 3D with an Experimental Medical Device (ESRIR)
This study is testing a new 3D imaging device to see if it can safely and effectively detect brain problems in patients with a specific type of stroke without moving them to another location.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Caen Academic / other |
| Locations | 1 site (Caen) |
| Trial ID | NCT06793839 on ClinicalTrials.gov |
What this trial studies
This study investigates a new non-invasive bedside device that utilizes 3D enhanced ultrasonography to detect complications in patients with aneurysmal subarachnoid hemorrhage (SAH). The device aims to provide better imaging of the brain's anterior circulation arteries without the need for intrahospital transportation, which can pose risks for critically ill patients. Participants will undergo three sessions of transcranial enhanced ultrasonography using a contrast agent, and the quality of the imaging will be assessed against clinical findings. The study seeks to demonstrate the feasibility and effectiveness of this innovative imaging approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been admitted to the neurologic ICU for an aneurysmal subarachnoid hemorrhage of the anterior circulation.
Not a fit: Patients with non-aneurysmal subarachnoid hemorrhage or those with contraindications to the ultrasound contrast agent will not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could improve the diagnosis and management of complications in patients suffering from aneurysmal subarachnoid hemorrhage.
How similar studies have performed: While transcranial doppler has been used effectively, this specific approach using 3D enhanced ultrasonography is novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Admitted in neurologic ICU of the CHU Caen, Normandy, for a subarachnoid hemorrhage of the anterior circulation. * Usable ultrasound temporal window. * 18 years old and more. * Consent of the participant or the trusted person. Exclusion Criteria: * non-aneurysmal subarachnoid haemorrhage. * Contraindication to ultrasound contrast agent Sonovue, including allergies to a compound. * Uncontrolled systemic hypertension. * Acute respiratory distress syndrome. * Pregnancy or breastfeeding mother. * Vulnerable person with guardianship or curatorship. * Patient not affiliated to french social security system (Sécurité Sociale)
Where this trial is running
Caen
- CAEN University Hospital — Caen, France (Recruiting)
Study contacts
- Principal investigator: Clément GAKUBA, PhD — University Hospital, Caen
- Study coordinator: Clément GAKUBA, PhD
- Email: gakuba-c@chu-caen.fr
- Phone: 0231063106
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.