Ultrasound for Acute Field Triage of Stroke

NCT05845203 | Completed DMC

• 1 other identifier: DR230049- USTRAFAST
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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, 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"

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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).

  1 day

Secondary Outcomes (1)

• Patient questionnaire on per-procedure comfort parameters

  1 day

Study Arms (1)

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/

Diagnostic Test: perform a simultaneous bilateral DTC acquisition of 20 seconds per hemisphere

Interventions

perform a simultaneous bilateral DTC acquisition of 20 seconds per hemisphere DIAGNOSTIC_TEST

perform a simultaneous bilateral DTC acquisition of 20 seconds per hemisphere

transcranial doppler and pulsatility measurements

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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).

You may not qualify if:

• (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.

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

BOULOUIS

Tours, 37000, France

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: May 6, 2023
• Study Start: October 3, 2023
• Primary Completion: December 10, 2025
• Study Completion: December 11, 2025
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

FR (1)