Subarachnoid HemorrhageESRIRNCT06793839
3D Contrast Enhanced Acoustic Perfusion Imaging in Adult After Subarachnoid Hemorrhage
A study testing Transcranial Enhanced Ultrasonography localizing microscopy in people with Subarachnoid Hemorrhage, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- Transcranial Enhanced Ultrasonography localizing microscopy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CAEN University Hospital
Caen, 14000
Clément GAKUBA, +33 6 64 00 17 20, gakuba-c@chu-caen.fr
About this study
Official title: 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)
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.
Read the detailed description
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.
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- Transcranial Enhanced Ultrasonography localizing microscopy
- Keywords
- aneurysmal, subarachnoid, hemorrhage, transcranial, doppler, ultrasonography, vasospasm, localizing, microscopy, delayed, cerebral, ischemia, aneurysm, anterior
- Medical subject headings
- Subarachnoid Hemorrhage, Hemorrhage, Ischemia, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Enhanced Ultrasonography localizing microscopyDevice
Also called MARIUS
3 bilateral transcranial enhanced (with Sonovue) ultrasonography per patient to visualize cranial arteries of the anterior circulation of the brain
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonography localizing microscopy 3D | Experimental | Enhanced (with Sonovue IV 2,4mL x2) transcranial ultrasonography Receives: Device: Transcranial Enhanced Ultrasonography localizing microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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
Measured: day 0-2 / day 4-10 / day 11-14
Variability of measurement
For each patient, bilateal ultrasonography will be done.
Measured: day 0-2 / day 4-10 / day 11-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start1 May 2024
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group of 15 patients with subarachnoïd hemorrhage
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- European Research Council
- Responsible party
- Sponsor
- Investigators
- Clément GAKUBA, PhD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793839
- Sponsor's protocol ID
- CHU 23-0184
- Other IDs
- 2023-A01978-37
- Acronym
- ESRIR
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 31973952Fung 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.
PubMed 35211837
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06793839
- Acronym / sponsor ID
- ESRIR / CHU 23-0184
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- aneurysmal, subarachnoid, hemorrhage, transcranial, doppler, ultrasonography, vasospasm, localizing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- European Research Council
- Study start
- 1 May 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group of 15 patients with subarachnoïd hemorrhage
| Arm | Type | Receives |
|---|---|---|
| Ultrasonography localizing microscopy 3D | Experimental | Device: Transcranial Enhanced Ultrasonography localizing microscopyEnhanced (with Sonovue IV 2,4mL x2) transcranial ultrasonography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Enhanced Ultrasonography localizing microscopyAlso: MARIUS3 bilateral transcranial enhanced (with Sonovue) ultrasonography per patient to visualize cranial arteries of the anterior circulation of the brain | Device | Ultrasonography localizing microscopy 3D |
Primary outcome
Presence of a time-intensity curve (TIC) of contrast agent / Quality of signal
Time frame: day 0-2 / day 4-10 / day 11-14
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.
3 secondary outcomes
Agreement between data from 3D ultrasonography localizing miroscopy and clinical parameters of early brain injury, cerebral vasospam and delayed cerebral ischemia
Time frame: day 0-2 / day 4-10 / day 11-14
Ability to detect principal arteries of anterior circulation
Time frame: day 0-2 / day 4-10 / day 11-14
Variability of measurement
Time frame: day 0-2 / day 4-10 / day 11-14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Background: PubMed 31973952Christensen-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.
- Background: PubMed 35211837Fung 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.
- Clinical Application of Super-resolution Ultrasound(SR-US) Imaging in Solid TumorsLink provided by the sponsor.
- SUper-Resolution Ultrasound Imaging of Erythrocytes (SURE) in Normal and Malignant Lymph NodesLink provided by the sponsor.
- Ultrasound Perfusion Imaging After Aneurysmal Subarachnoid Hemorrhage (PSAB)Link provided by the sponsor.
- Contrast Enhanced Ultrasound Imaging for Cerebral Perfusion Measurement in Cerebral Vasospasm After SAHLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clément GAKUBA, PhD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Enhanced Ultrasonography localizing microscopy in people with Subarachnoid Hemorrhage, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clément GAKUBA, PhD (0231063106 ext. +33, gakuba-c@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of a time-intensity curve (TIC) of contrast agent / Quality of signal (time frame: day 0-2 / day 4-10 / day 11-14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06793839, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.