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NCT Number: NCT06570681

Video Call Assisted Assessment of Acute Stroke

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology

Aabenraa, Region Syddanmark, 6200, Denmark

Location status: Recruiting

About this study

Treatment of stroke with either thrombolysis or thrombectomy is highly time-dependent (administration within 4.5 hours and 24 hours from symptom onset, respectively), and morbidity and mortality increase with time from symptom onset to treatment. Hence, prehospital evaluation and transport must be as accurate and rapid as possible in order to minimise time to treatment.

Different triage and transport paradigms for patients with suspected stroke are being investigated and multiple stroke scales have been coined in order to examine patients suspected of stroke in a prehospital setting. However, performance and feasibility vary greatly in different validation studies suggesting that those outcomes are greatly dependent on other factors i.e. acceptance amongst stakeholders, implementation process, patient segment etc. Some recent studies have shown promising results using video solutions between emergency medical services (EMS) personnel and on-call neurologist in examining patients suspected of stroke in the prehospital phase. The investigators will perform this trial to examine whether a video call assisted assessment of patients suspected of stroke in a prehospital setting can increase feasibility and performance of symptom-based prehospital stroke scales.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Suspected stroke within 24 hours from onset (confirmed with Prehospital Stroke 1 decision tool)
  • Age >18 years

Exclusion criteria

  • Suspected stroke more than 24 hours ago
  • In-hospital stroke or private transport to hospital
  • Unconsciousness defined as Glasgow Coma Score (GCS) ≤ 8 (as they cannot be rated)

Treatment and study plan

Video call assisted assessment of acute stroke

Diagnostic Test

If the patient is eligible for study inclusion, eight symptoms from the study protocol are evaluated and registered in the Prehospital Patient Journal (PPJ) on the amPHITM Prehospital Health Care Record (Amphi Systems, Hasserisvej 125, 9000 Aalborg, Denmark), on a tablet mounted in each EMT vehicle. Afterwards, the EMS personnel will contact the on-call neurologist and if the vehicle is in the intervention arm a live video stream is initiated. The on-call neurologist then examines the patient via via the video-call and triages the patient.

Primary outcomes

  1. Acute ischemic stroke (AIS) or transient ischemic attack (TIA) diagnosis at discharge

    Time frame: At discharge, assessed within one week from symptom onset

    AIS or TIA as diagnosis. (binary outcome)

Secondary outcomes

  1. Number of patients with acute ischemic stroke (AIS) with LVO on neuroimaging

    Time frame: Within 48 hours of admission

    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).

  2. Number of patients with Other large vessel AIS

    Time frame: at admission

    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).

  3. Number of patients with verified acute ischemic stroke (AIS) on neuroimaging

    Time frame: Within 48 hours of admission

    Neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography) with AIS

  4. Number of patients with Haemorrhagic stroke

    Time frame: at admission

    Neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography) with intra cranial haemorrhage (ICH) (binary outcome)

Other outcomes

  1. Duration of examination on video-call

    Time frame: up to 120 minutes prior to admission (prehospital phase)

    Duration of examination on video-call measured in minutes (continuous outcome)

  2. Number of patients which have mimic mistaken for stroke

    Time frame: Through study completion, approximately 2 months

    Mimic mistaken for stroke evaluated as discrepancy between stroke as tentative diagnoses at primary contact from EMS and final diagnosis at discharge

  3. Prehospital time on scene

    Time frame: up to 120 minutes prior to admission (prehospital phase)

    Time on scene from arrival EMS to departure EMS measured in minutes (continuous outcome)

  4. Type of department patient is admitted to after consultation with the neurologist

    Time frame: At admission

    Where was the patient sent after telephone/video consultation with the on-call neurologist.

  5. Door-in-door-out (DIDO) time

    Time frame: at admission

    DIDO times for patients subsequently sent to comprehensive stroke unit for thrombectomy treatment.

  6. Door-to-needle (DNT) time

    Time frame: at admission

    DNT times for patients receiving thrombolysis

  7. Door-to-Groin-Puncture (DTGP) time

    Time frame: within 24 hours of admission

    DTGP times for patients receiving treatment with thrombectomy

  8. Onset-to-Groin-Puncture (OTP) time

    Time frame: within 24 hours of admission

    OTP for patients receiving treatment with thrombectomy

  9. 90 days modified Ranking Scale (mRS)

    Time frame: 90 days post admission date

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Christian Backer Mogensen

CONTACT

[email protected]

+45 79 97 00 00

Trine Nielsen

CONTACT

[email protected]

+45 79 97 00 00

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Official study title

Video Call Assisted Assessment of Acute Stroke in Addition to Stroke Scales in a Prehospital Setting: A Cluster Randomised Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2024
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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