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Ultrasound for Acute Field Triage of Stroke (USTRAFAST)

Primary Purpose

Acute Ischemic Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
perform a simultaneous bilateral DTC acquisition of 20 seconds per hemisphere
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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). Exclusion Criteria: (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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    transcranial doppler and pulsatility measurements

    Arm Description

    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/

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    March 30, 2023
    Last Updated
    May 2, 2023
    Sponsor
    University Hospital, Tours
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05845203
    Brief Title
    Ultrasound for Acute Field Triage of Stroke
    Acronym
    USTRAFAST
    Official Title
    Ultrasound for Acute Field Triage of Stroke: a Pilot Study- Ustrafast
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    July 2, 2024 (Anticipated)
    Study Completion Date
    July 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Tours

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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"
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Ischemic Stroke

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    transcranial doppler and pulsatility measurements
    Arm Type
    Experimental
    Arm Description
    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/
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    perform a simultaneous bilateral DTC acquisition of 20 seconds per hemisphere
    Intervention Description
    perform a simultaneous bilateral DTC acquisition of 20 seconds per hemisphere
    Primary Outcome Measure Information:
    Title
    Measurements of cerebral pulsatility (maximum and average), peak diastolic and systolic velocity, peak systolic velocity, resistance index and pulsatility
    Description
    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).
    Time Frame
    1 day
    Secondary Outcome Measure Information:
    Title
    Patient questionnaire on per-procedure comfort parameters
    Description
    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.
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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). Exclusion Criteria: (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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    BOULOUIS Grégoire, Dr
    Phone
    02 47 47 47 25
    Email
    g.boulouis@chu-tours.fr

    12. IPD Sharing Statement

    Learn more about this trial

    Ultrasound for Acute Field Triage of Stroke

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