3D Contrast Enhanced Acoustic Perfusion Imaging in Adult After Subarachnoid Hemorrhage

NCT06793839 | Recruiting

• 2 other identifiers: CHU 23-01842023-A01978-37
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Aneurysmal subarachnoid hemorrhage (SAH) is a devastating form of stroke, with three major complications : early brain injury (EBI), vasospasm and delayed cerebral ischemia (DCI). Those patients are often given care in neurocritical care. Imaging is particularly useful to diagnose these complications. Brain imaging includes CT scan, MRI and arteriography which are not easily available and need an intrahospital transportation. Furthermore, intrahospital transportation of critically ill patients is associated with significant complications Here, investigators try to show that a new non-invasive bedside device, based on 3D enhanced ultrasonography, is able to detect principal arteries of anterior circulation of the brain.

Conditions

Subarachnoid Hemorrhage

Keywords

aneurysmal; subarachnoid; hemorrhage; transcranial; doppler; ultrasonography; vasospasm; localizing; microscopy; delayed; cerebral; ischemia; aneurysm; anterior

Outcome Measures

Primary Outcomes (1)

• Presence of a time-intensity curve (TIC) of contrast agent / Quality of signal

  Mathematical models may be used to estimate blood flow parameters after the administration of microbubble contrast agents. A time-intensity curve (TIC) may be created to reflect the intravascular transit of the contrast agent. TICs reflect the average intensity in a region of interest, measured in absolute intensity units, over time in seconds. Plotting TIC in a given frame allows for quantification of various parameters, including time to peak, peak intensity, area under the curve, wash-in and wash-out time, and mean transit time. Some of these parameters, such as peak intensity and area under the curve, reflect local blood volume in the region of interest, whereas, other parameters (time to peak intensity, wash-in/wash-out time) are more reflective of blood flow.

  day 0-2 / day 4-10 / day 11-14

Secondary Outcomes (3)

• Agreement between data from 3D ultrasonography localizing miroscopy and clinical parameters of early brain injury, cerebral vasospam and delayed cerebral ischemia

  day 0-2 / day 4-10 / day 11-14

• Ability to detect principal arteries of anterior circulation

  day 0-2 / day 4-10 / day 11-14

• Variability of measurement

  day 0-2 / day 4-10 / day 11-14

Study Arms (1)

Ultrasonography localizing microscopy 3D

EXPERIMENTAL

Enhanced (with Sonovue IV 2,4mL x2) transcranial ultrasonography

Device: Transcranial Enhanced Ultrasonography localizing microscopy

Interventions

Transcranial Enhanced Ultrasonography localizing microscopy DEVICE

3 bilateral transcranial enhanced (with Sonovue) ultrasonography per patient to visualize cranial arteries of the anterior circulation of the brain

Also known as: MARIUS

Ultrasonography localizing microscopy 3D

Eligibility Criteria

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

You may qualify if:

• Admitted in neurologic ICU of the CHU Caen, Normandy, for a subarachnoid hemorrhage of the anterior circulation.
• Usable ultrasound temporal window.
• years old and more.
• Consent of the participant or the trusted person.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Caen: lead
• European Research Council: collaborator

Study Sites (1)

CAEN University Hospital

Caen, 14000, France

RECRUITING

Related Publications (2)

• Ghendon Y. WHO recommendation on potential use of new poliomyelitis vaccines. Dev Biol Stand. 1993;78:133-7; discussion 138-9.

  PMID: 8388823 BACKGROUND

• Shea SS, Selfridge-Thomas J. The ED nurse practitioner: pearls and pitfalls of role transition and development. J Emerg Nurs. 1997 Jun;23(3):235-7. doi: 10.1016/s0099-1767(97)90014-3. No abstract available.

  PMID: 9283360 BACKGROUND

Related Links

• Clinical Application of Super-resolution Ultrasound(SR-US) Imaging in Solid Tumors
• SUper-Resolution Ultrasound Imaging of Erythrocytes (SURE) in Normal and Malignant Lymph Nodes
• Ultrasound Perfusion Imaging After Aneurysmal Subarachnoid Hemorrhage (PSAB)
• Contrast Enhanced Ultrasound Imaging for Cerebral Perfusion Measurement in Cerebral Vasospasm After SAH

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Hemorrhage; Ischemia; Aneurysm

Condition Hierarchy (Ancestors)

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

Study Officials

• Clément GAKUBA, PhD

  CHU CAEN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clément GAKUBA, PhD

CONTACT

0231063106; gakuba-c@chu-caen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The investigator and care provider can't see the imaging results.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group of 15 patients with subarachnoïd hemorrhage

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: January 27, 2025
• Study Start: May 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: January 27, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)