Video Call Assisted Assessment of Acute Stroke
NCT Number: NCT06570681
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke|Cerebrovascular Disorders|Brain Diseases|Nervous System Diseases|Vascular Diseases|Central Nervous System Diseases
Interventions: DIAGNOSTIC_TEST: Video call assisted assessment of acute stroke
Sponsor: University of Southern Denmark
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 512
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-05-27
Completion Date: 2026-03-03
Locations: Department of Neurology, Aabenraa, South Denmark, 6200, Denmark

Summary:
This study aims to investigate whether a live stream video between the on-call neurologist and the emergency medical technicians can increase feasibility and performance of symptom-based prehospital stroke scales.

Primary Outcome Measures: Acute ischemic stroke (AIS) or transient ischemic attack (TIA) diagnosis at discharge, AIS or TIA as diagnosis. (binary outcome), At discharge, assessed within one week from symptom onset
Secondary Outcome Measures: Number of patients with acute ischemic stroke (AIS) with LVO on neuroimaging, AIS with LVO on neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography). LVO is defined as a occlusion or sub-occlusion of the intracranial internal carotid artery, middle cerebral artery M1 or M2, basilar artery. Sign of dense cerebral artery on CT is also considered LVO positive. (binary outcome)., Within 48 hours of admission|Number of patients with Other large vessel AIS, Neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography) with AIS with occlusion or sub-occlusion of either anterior cerebral artery A1 or A2, posterior cortical artery P1 or intracranial vertebral artery (binary outcome)., at admission|Number of patients with verified acute ischemic stroke (AIS) on neuroimaging, Neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography) with AIS, Within 48 hours of admission|Number of patients with Haemorrhagic stroke, Neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography) with intra cranial haemorrhage (ICH) (binary outcome), at admission
Other Outcome Measures: Duration of examination on video-call, Duration of examination on video-call measured in minutes (continuous outcome), up to 120 minutes prior to admission (prehospital phase)|Number of patients which have mimic mistaken for stroke, Mimic mistaken for stroke evaluated as discrepancy between stroke as tentative diagnoses at primary contact from EMS and final diagnosis at discharge, Through study completion, approximately 2 months|Prehospital time on scene, Time on scene from arrival EMS to departure EMS measured in minutes (continuous outcome), up to 120 minutes prior to admission (prehospital phase)|Type of department patient is admitted to after consultation with the neurologist, Where was the patient sent after telephone/video consultation with the on-call neurologist., At admission|Door-in-door-out (DIDO) time, DIDO times for patients subsequently sent to comprehensive stroke unit for thrombectomy treatment., at admission|Door-to-needle (DNT) time, DNT times for patients receiving thrombolysis, at admission|Door-to-Groin-Puncture (DTGP) time, DTGP times for patients receiving treatment with thrombectomy, within 24 hours of admission|Onset-to-Groin-Puncture (OTP) time, OTP for patients receiving treatment with thrombectomy, within 24 hours of admission|90 days modified Ranking Scale (mRS), Modified Rankin Scale score in stroke patients as evaluated through a structured telephone-based interview performed by a central assessor who is blinded to group assignment, 90 days post admission date