Acute Ischemic StrokeUSTRAFASTNCT05845203
Ultrasound for Acute Field Triage of Stroke
A study testing perform a simultaneous bilateral DTC acquisition of 20 seconds per hemisphere in people with Acute Ischemic Stroke, run by University Hospital, Tours at 1 site in France.
Trial summary
Acute ischemic stroke (AIS) is responsible for considerable morbidity and mortality worldwide and has serious medico-economic and psychosocial consequences. Before the advent of mechanical thrombectomy (TM), care and telestroke networks had focused their efforts on the rapid administration of a thrombolytic agent… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- perform a simultaneous bilateral DTC acquisition of 20 seconds per hemisphere
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2023to 11 Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects (recruitment via the CIC-IC):
- Adults (Age >18),
- free from any known cerebral pathology,
- having given their informed, dated and signed free consent
- and affiliated with a French social security scheme (CMU accepted)
- Stroke topics:
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- Adult patients (age >18 years),
- admission for suspected stroke with a severity scale assessed by an NIH Stroke Scale > 10 with or without signs of cortical damage.
- Onset of symptoms < 24 hours.
- Proximal arterial occlusion confirmed by angio-MRI or angio-scan,
- free informed consent, dated and signed,
- affiliated to a French social security scheme (CMU accepted).
Who cannot join
- (healthy subjects and patients)
- Realization of the transcranial Doppler likely to delay the treatment of the patient
- Patient eligible for thrombectomy. vs
- Major agitation (+3 on the Richmond Agitation Sedation Scale) (done only when the patient is agitated).
- Inability of the patient to consent due to the severity of the clinical symptoms, and the absence of an available relative.
- History of severe head trauma, or significant deformation of the skull.
- Recent craniofacial trauma with recent scalp or facial wounds.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound for Acute Field Triage of Stroke: a Pilot Study- Ustrafast
Acute ischemic stroke (AIS) is responsible for considerable morbidity and mortality worldwide and has serious medico-economic and psychosocial consequences. Before the advent of mechanical thrombectomy (TM), care and telestroke networks had focused their efforts on the rapid administration of a thrombolytic agent, tissue plasminogen activator (tPA), intravenously ( IV), to all eligible patients with ischemic stroke. These care networks have been shown to improve both patient prognosis by improving early vascular recanalization, the overall quality of neurovascular care within the network, and costs at network hospitals.
In 2015, the effectiveness of another treatment, TM, for some acute ischemic stroke patients with large vessel occlusion (LVO) created new challenges for the effective triage of suspected patients stroke, especially in the prehospital setting.Indeed, non-OLV patients should receive intravenous thrombolysis without delay and thus should be transported to the nearest facility with neurological capacity. thrombolysis.In contrast, the efficacy of thrombolysis remains limited for patients with LVO stroke who likely benefit from direct transport from the field to a comprehensive stroke center capable of performing TM. In these patients, stopping at a local center to initiate thrombolysis can delay revascularization and worsen the prognosis.These sorting strategy paradigms, called "mothership" and "drip and ship"
Read the detailed description
Investigators hypothesize that the use of a compact DTC system may optimize prehospital triage of participants with suspected stroke by EMS emergency medical services with rapid applicability and limited training required. The objectives of this study will be to:
- assess the role of cerebral pulsatility index as a marker of proximal vessel occlusion, and its added value to PSV, EDV, RI and MV,
- optimize the engineering and ergonomics parameters of the DTC mechanical support system,
- test its speed of application on healthy subjects, then on participants who have suffered a confirmed stroke, and
- to use this data to derive a fully operational DTC system and a dedicated interface for a larger scale real test in a pre-hospital setting.
- Conditions
- Acute Ischemic Stroke
- Being tested
- perform a simultaneous bilateral DTC acquisition of 20 seconds per hemisphere
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perform a simultaneous bilateral DTC acquisition of 20 seconds per hemisphereDiagnostic test
perform a simultaneous bilateral DTC acquisition of 20 seconds per hemisphere
| Study group | Role | What they receive |
|---|---|---|
| transcranial doppler and pulsatility measurements | Experimental | PATIENT and HEALTHY VOLUNTEERS:
The intervention consists of:
- perform a simultaneous bilateral DTC acquisition of 20 seconds per hemisphere, and The ultrasound system used will be: ArtUS ultrasound system (Telemed, Vilnius, Lithuania), with transcranial probe P5-1S15-A6.
Two identical devices (ultrasound + probe) will be used, each scanning a cerebral hemisphere. They each carry the CE mark and will be used in accordance with the CE mark. https://www.pcultrasound.com/products/products_artus/ Receives: Diagnostic Test: perform a simultaneous bilateral DTC acquisition of 20 seconds per hemisphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of cerebral pulsatility (maximum and average), peak diastolic and systolic velocity, peak systolic velocity, resistance index and pulsatility
The main outcome is to measure the cerebral pulsatility which will be assessed by all this diiferents measures in the same time such as : Peack diastolic and systoic velocity in cm/sec which will help to determine the resistance index and the pulsatility index at end with the help of the transcranial doppler at letf side and right side. The parameters will be compared at the level of a patient (healthy vs pathological hemisphere), and of the hemispheres (all healthy vs pathological hemispheres).
Measured: 1 day
Secondary outcomes (1)
Patient questionnaire on per-procedure comfort parameters
he secondary outcomes are to evaluate if wearing a support to assesed the pulsatility billateraly might generate some disconfort to the patient. That is why we will use one of the universal scale, the Likert confort to disconfort scale to evaluate disconfort from the great confort imaginale to the great disconfort imaginable of the participants.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start3 Oct 2023
- Primary completion10 Dec 2025
- Study completion11 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845203
- Sponsor's protocol ID
- DR230049- USTRAFAST
- Acronym
- USTRAFAST
- Status last verified
- Jun 2026
- First submitted
- 30 Mar 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound for Acute Field Triage of Stroke: a Pilot Study- Ustrafast
- ClinicalTrials.gov ID
- NCT05845203
- Acronym / sponsor ID
- USTRAFAST / DR230049- USTRAFAST
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 11 Dec 2025 (actual)
- First posted
- 6 May 2023 (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.
Acute ischemic stroke (AIS) is responsible for considerable morbidity and mortality worldwide and has serious medico-economic and psychosocial consequences. Before the advent of mechanical thrombectomy (TM), care and telestroke networks had focused their efforts on the rapid administration of a thrombolytic agent, tissue plasminogen activator (tPA), intravenously ( IV), to all eligible patients with ischemic stroke. These care networks have been shown to improve both patient prognosis by improving early vascular recanalization, the overall quality of neurovascular care within the network, and costs at network hospitals.
In 2015, the effectiveness of another treatment, TM, for some acute ischemic stroke patients with large vessel occlusion (LVO) created new challenges for the effective triage of suspected patients stroke, especially in the prehospital setting.Indeed, non-OLV patients should receive intravenous thrombolysis without delay and thus should be transported to the nearest facility with neurological capacity. thrombolysis.In contrast, the efficacy of thrombolysis remains limited for patients with LVO stroke who likely benefit from direct transport from the field to a comprehensive stroke center capable of performing TM. In these patients, stopping at a local center to initiate thrombolysis can delay revascularization and worsen the prognosis.These sorting strategy paradigms, called "mothership" and "drip and ship"
Detailed description
Investigators hypothesize that the use of a compact DTC system may optimize prehospital triage of participants with suspected stroke by EMS emergency medical services with rapid applicability and limited training required. The objectives of this study will be to:
- assess the role of cerebral pulsatility index as a marker of proximal vessel occlusion, and its added value to PSV, EDV, RI and MV,
- optimize the engineering and ergonomics parameters of the DTC mechanical support system,
- test its speed of application on healthy subjects, then on participants who have suffered a confirmed stroke, and
- to use this data to derive a fully operational DTC system and a dedicated interface for a larger scale real test in a pre-hospital setting.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transcranial doppler and pulsatility measurements | Experimental | Diagnostic Test: perform a simultaneous bilateral DTC acquisition of 20 seconds per hemispherePATIENT and HEALTHY VOLUNTEERS: The intervention consists of: - perform a simultaneous bilateral DTC acquisition of 20 seconds per hemisphere, and The ultrasound system used will be: ArtUS ultrasound system (Telemed, Vilnius, Lithuania), with transcranial probe P5-1S15-A6. Two identical devices (ultrasound + probe) will be used, each scanning a cerebral hemisphere. They each carry the CE mark and will be used in accordance with the CE mark. https://www.pcultrasound.com/products/products_artus/ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adults (Age >18),
- free from any known cerebral pathology,
- having given their informed, dated and signed free consent
- and affiliated with a French social security scheme (CMU accepted)
- Adult patients (age >18 years),
Key exclusion criteria (7 listed)
- (healthy subjects and patients)
- Realization of the transcranial Doppler likely to delay the treatment of the patient
- Patient eligible for thrombectomy. vs
- Major agitation (+3 on the Richmond Agitation Sedation Scale) (done only when the patient is agitated).
- Inability of the patient to consent due to the severity of the clinical symptoms, and the absence of an available relative.
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 |
|---|---|---|
| perform a simultaneous bilateral DTC acquisition of 20 seconds per hemisphereperform a simultaneous bilateral DTC acquisition of 20 seconds per hemisphere | Diagnostic test | transcranial doppler and pulsatility measurements |
Primary outcome
Measurements of cerebral pulsatility (maximum and average), peak diastolic and systolic velocity, peak systolic velocity, resistance index and pulsatility
Time frame: 1 day
The main outcome is to measure the cerebral pulsatility which will be assessed by all this diiferents measures in the same time such as : Peack diastolic and systoic velocity in cm/sec which will help to determine the resistance index and the pulsatility index at end with the help of the transcranial doppler at letf side and right side. The parameters will be compared at the level of a patient (healthy vs pathological hemisphere), and of the hemispheres (all healthy vs pathological hemispheres).
1 secondary outcome
Patient questionnaire on per-procedure comfort parameters
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing perform a simultaneous bilateral DTC acquisition of 20 seconds per hemisphere in people with Acute Ischemic Stroke, run by University Hospital, Tours 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 12 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: finished, as of the sponsor's last update on 16 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurements of cerebral pulsatility (maximum and average), peak diastolic and systolic velocity, peak systolic velocity, resistance index and pulsatility (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2026.