Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A01978-37 | Registry Identifier | ID RCB (ANSM) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| European Research Council | OTHER |
Not provided
Not provided
Not provided
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.
Introduction: Aneurysmal subarachnoid hemorrhage (SAH) is a devastating form of hemorrhagic stroke. Majors complications of aneurysmal SAH include early brain injury (EBI), vasospam and delayed cerebral ischemia (DCI). There are currently only few ways through imaging to diagnose those complication. Transcranial doppler (TCD) is an accessible bedside tool which is efficient, but can only provide indirect evidences. Other brain imaging includes CT scan, MRI and arteriography which are not easily available and are associated with intrahospital transportation of critically ill patients and its morbidity. There are several preclinical evidences that 3D enhanced ultrasonography localizing microscopy could show similar images resolution to angiography while being more accessible.
Materials and methods: this study will include patients with aneurysmal SAH. Aneurysm must be of anterior circulation.The investigators will perform a feasibility research with a new medical device based on ultrasonography localizing microscopy. The standard of care will not be changed, but each patient will also get three bilateral transcranial enhanced (with microbubbles from Sonovue) ultrasonography, one for each period at risk (J0-J2, J4-10, J11-J14). The primary outcome will be the quality of time-intensity curve of the contrast agent, in order to show the quality of signal received. Then, as a secondary outcome, images will be compared to clinical findings. As a pilot study, the investigators plan to include only 15 patients in a monocentric trial.
This device could provide real-time information on blood flow and potential complications such as vasospasm or DCI, allowing for earlier intervention and potentially improving outcomes for SAH patients. Additionally, the bedside nature of this device eliminates the need for intrahospital transportation, reducing the risk of complications associated with moving critically ill patients.
This study aims to assess the feasibility and potential benefits of using 3D enhanced ultrasonography localizing microscopy in the management of aneurysmal SAH. The results of this pilot study could pave the way for larger clinical trials and ultimately lead to improved outcomes for patients with this devastating condition.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasonography localizing microscopy 3D | Experimental | Enhanced (with Sonovue IV 2,4mL x2) transcranial ultrasonography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clément GAKUBA, PhD | Contact | 0231063106 | +33 | gakuba-c@chu-caen.fr |
| Name | Affiliation | Role |
|---|---|---|
| Clément GAKUBA, PhD | University Hospital, Caen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAEN University Hospital | Recruiting | Caen | 14000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31973952 | Background | Christensen-Jeffries K, Couture O, Dayton PA, Eldar YC, Hynynen K, Kiessling F, O'Reilly M, Pinton GF, Schmitz G, Tang MX, Tanter M, van Sloun RJG. Super-resolution Ultrasound Imaging. Ultrasound Med Biol. 2020 Apr;46(4):865-891. doi: 10.1016/j.ultrasmedbio.2019.11.013. Epub 2020 Jan 21. | |
| 35211837 | Background |
| Label | URL |
|---|---|
| Clinical Application of Super-resolution Ultrasound(SR-US) Imaging in Solid Tumors | View source |
Not provided
IPD won't be shared with other researchers. Data will be collected in a data base with an authentification by password. The used system is in accordance with the french law, notably MR-01. Only permitted person will be given an access to the data base. Every connection to the data base will be recorded.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| D006470 | Hemorrhage |
| D007511 | Ischemia |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Single group of 15 patients with subarachnoïd hemorrhage
Not provided
Not provided
The investigator and care provider can't see the imaging results.
Not provided
|
| day 0-2 / day 4-10 / day 11-14 |
| 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 | day 0-2 / day 4-10 / day 11-14 |
| Variability of measurement | For each patient, bilateal ultrasonography will be done. | day 0-2 / day 4-10 / day 11-14 |
| Fung C, Heiland DH, Reitmeir R, Niesen WD, Raabe A, Eyding J, Schnell O, Rolz R, Z Graggen WJ, Beck J. Ultrasound Perfusion Imaging for the Detection of Cerebral Hypoperfusion After Aneurysmal Subarachnoid Hemorrhage. Neurocrit Care. 2022 Aug;37(1):149-159. doi: 10.1007/s12028-022-01460-z. Epub 2022 Feb 24. |
| SUper-Resolution Ultrasound Imaging of Erythrocytes (SURE) in Normal and Malignant Lymph Nodes | View source |
| Ultrasound Perfusion Imaging After Aneurysmal Subarachnoid Hemorrhage (PSAB) | View source |
| Contrast Enhanced Ultrasound Imaging for Cerebral Perfusion Measurement in Cerebral Vasospasm After SAH | View source |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |