StrokeNCT06570681
Video Call Assisted Assessment of Acute Stroke
A study testing Video call assisted assessment of acute stroke in people with Stroke and Cerebrovascular Disorders, run by University of Southern Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cerebrovascular Disorders, Brain Diseases
- What is being tested?
- Video call assisted assessment of acute stroke
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- 1 siteDenmark
- Study dates
- 27 May 2024to 3 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspected stroke within 24 hours from onset (confirmed with Prehospital Stroke 1 decision tool)
- Age >18 years
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Neurology
Aabenraa, Region Syddanmark, 6200
About this study
Official title: Video Call Assisted Assessment of Acute Stroke in Addition to Stroke Scales in a Prehospital Setting: A Cluster Randomised Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Stroke, Cerebrovascular Disorders, Brain Diseases, Nervous System Diseases, Vascular Diseases, Central Nervous System Diseases
- Being tested
- Video call assisted assessment of acute stroke
- Medical subject headings
- Stroke, Cerebrovascular Disorders, Brain Diseases, Nervous System Diseases, Vascular Diseases, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Video call assisted assessment of acute stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute ischemic stroke (AIS) or transient ischemic attack (TIA) diagnosis at discharge
AIS or TIA as diagnosis. (binary outcome)
Measured: At discharge, assessed within one week from symptom onset
Secondary outcomes (4)
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).
Measured: 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).
Measured: 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
Measured: 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)
Measured: at admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start27 May 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion3 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 512 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570681
- Sponsor's protocol ID
- SHS-Neuro-1-2024
- Status last verified
- May 2026
- First submitted
- 28 May 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Call Assisted Assessment of Acute Stroke in Addition to Stroke Scales in a Prehospital Setting: A Cluster Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06570681
- Acronym / sponsor ID
- SHS-Neuro-1-2024
- Conditions
- Stroke, Cerebrovascular Disorders, Brain Diseases, Nervous System Diseases, Vascular Diseases, Central Nervous System Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 512 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 27 May 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 3 Dec 2026 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Diagnostic Test: Video call assisted assessment of acute strokeIf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Suspected stroke within 24 hours from onset (confirmed with Prehospital Stroke 1 decision tool)
- Age >18 years
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video call assisted assessment of acute strokeIf 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. | Diagnostic test | Video call assisted assessment of acute stroke |
Primary outcome
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)
4 secondary outcomes
Number of patients with acute ischemic stroke (AIS) with LVO on neuroimaging
Time frame: Within 48 hours of admission
Number of patients with Other large vessel AIS
Time frame: at admission
Number of patients with verified acute ischemic stroke (AIS) on neuroimaging
Time frame: Within 48 hours of admission
Number of patients with Haemorrhagic stroke
Time frame: at admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video call assisted assessment of acute stroke in people with Stroke and Cerebrovascular Disorders, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trine Nielsen (+45 79 97 00 00, Trine.Nielsen2@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute ischemic stroke (AIS) or transient ischemic attack (TIA) diagnosis at discharge (time frame: At discharge, assessed within one week from symptom onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.