NCT06570681

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
512

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 28, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2026

Completed
Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

1.4 years

First QC Date

May 28, 2024

Last Update Submit

September 18, 2025

Conditions

StrokeCerebrovascular DisordersBrain DiseasesNervous System DiseasesVascular DiseasesCentral Nervous System Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

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

    Within 48 hours of admission

  • Number of patients with Other large vessel AIS

    at admission

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

    Within 48 hours of admission

  • Number of patients with Haemorrhagic stroke

    at admission

Other Outcomes (9)

  • Duration of examination on video-call

    up to 120 minutes prior to admission (prehospital phase)

  • Number of patients which have mimic mistaken for stroke

    Through study completion, approximately 2 months

  • Prehospital time on scene

    up to 120 minutes prior to admission (prehospital phase)

  • +6 more other outcomes

Study Arms (2)

Standard Care

NO INTERVENTION

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. If the vehicle is in the control arm the patient is triaged by the on-call neurologist based on a standard telephone call

Video call assisted assessment of acute stroke

ACTIVE COMPARATOR

If the patient is eligible for study inclusion, the last 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 the video-call and triage the patient.

Diagnostic Test: Video call assisted assessment of acute stroke

Interventions

Video call assisted assessment of acute strokeDIAGNOSTIC_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.

Video call assisted assessment of acute stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology

Aabenraa, Region Syddanmark, 6200, Denmark

RECRUITING

MeSH Terms

Conditions

StrokeCerebrovascular DisordersBrain DiseasesNervous System DiseasesVascular DiseasesCentral Nervous System Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Central Study Contacts

Trine Nielsen

CONTACT

+45 79 97 00 00Trine.Nielsen2@rsyd.dk

Christian Backer Mogensen

CONTACT

+45 79 97 00 00CBM1@rsyd.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2024

First Posted

August 26, 2024

Study Start

May 27, 2024

Primary Completion

November 1, 2025

Study Completion

March 3, 2026

Last Updated

September 24, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)