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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Caen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

non-aneurysmal subarachnoid haemorrhage.

Contraindication to ultrasound contrast agent Sonovue, including allergies to a compound.

Uncontrolled systemic hypertension.

Acute respiratory distress syndrome.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Ultrasonography localizing microscopy 3DExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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

Morphology : Visually compare images from ULM and angiography or vasculary atlas Speed : Each side compared to classical temporal doppler ultrasonography Caliber : Mesure of principal arteries' diameter and compare with angiography Perfusion : Time-intensity curve's parameter of each side

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

Ability to detect principal arteries of anterior circulation

Questionnary filled by the investigator's and research team with the number and size of correct identified vessels

Time frame
day 0-2 / day 4-10 / day 11-14
3

Variability of measurement

For each patient, bilateal ultrasonography will be done.

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

Other outcomes

Sponsors and contacts

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University Hospital, Caen

Lead sponsor

European Research Council

Collaborator