Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-25 @ 4:47 PM
Study NCT ID:
NCT05845203
Status:
UNKNOWN
Last Update Posted:
2023-05-06
First Post:
2023-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound for Acute Field Triage of Stroke
Sponsor:
University Hospital, Tours
Organization:
Study Overview
Official Title:
Ultrasound for Acute Field Triage of Stroke: a Pilot Study- Ustrafast
Status:
UNKNOWN
Status Verified Date:
2023-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
USTRAFAST
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"
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:
1. assess the role of cerebral pulsatility index as a marker of proximal vessel occlusion, and its added value to PSV, EDV, RI and MV,
2. optimize the engineering and ergonomics parameters of the DTC mechanical support system,
3. test its speed of application on healthy subjects, then on participants who have suffered a confirmed stroke, and
4. 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.
1. assess the role of cerebral pulsatility index as a marker of proximal vessel occlusion, and its added value to PSV, EDV, RI and MV,
2. optimize the engineering and ergonomics parameters of the DTC mechanical support system,
3. test its speed of application on healthy subjects, then on participants who have suffered a confirmed stroke, and
4. 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: