StrokeASTRALNCT07657117
Telestroke Triage in Suspected Stroke Patients
A study testing Telestroke triage in people with Stroke, run by Nyika D. Kruyt at 1 site in Netherlands.
Trial summary
The ASTRAL trial is a randomized study in patients with suspected stroke in the ambulance setting. The study evaluates whether prehospital telestroke consultation, in addition to standard care, can reduce unnecessary stroke code activations and improve patient triage, treatment efficiency, and resource use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Telestroke triage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 518 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2026to 1 Mar 2028
- 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
- Age 18 years or older
- Stroke code activation by ambulance professional during office hours
- Symptom onset < 24 hours or uncertain onset
- The patient is deemed capable of understanding the study information and making a decision about participation/opt-out
Who cannot join
- Age under 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Robert Croese, MD contact
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2333 ZA
About this study
Official title: Ambulance Stroke Triage Assisted by Telemedicine (ASTRAL) Trial.
The ASTRAL trial is a randomized study in patients with suspected stroke in the ambulance setting. The study evaluates whether prehospital telestroke consultation, in addition to standard care, can reduce unnecessary stroke code activations and improve patient triage, treatment efficiency, and resource use. Participants are randomized to telestroke triage plus standard care or standard care alone. Outcomes include unnecessary stroke code activation, patient allocation, treatment times, functional outcome, safety, and cost-effectiveness.
Read the detailed description
The Ambulance Stroke Triage Assisted by Telemedicine (ASTRAL) trial is a prospective, randomized controlled trial in suspected stroke patients attended by ambulance professionals in the RAV Hollands Midden region. Patients aged 18 years or older with stroke code activation during office hours and symptom onset within 24 hours are randomized 1:1 to telestroke triage plus standard care or standard care alone. The intervention consists of real-time video and audio consultation with an on-duty neurologist who advises on stroke probability, destination, and urgency of transport, while ambulance professionals retain final decision authority. The primary endpoint is unnecessary stroke code activation. Secondary endpoints include allocation accuracy, safety, door-to-needle and door-to-groin times, modified Rankin Scale at 3 months, health-related quality of life, healthcare utilization, stakeholder satisfaction, and cost-effectiveness. Outcome assessors for 3-month follow-up measures are blinded to allocation. Data are collected in Castor EDC, and analyses follow the intention-to-treat principle
- Conditions
- Stroke
- Being tested
- Telestroke triage, Standard Care (in control arm)
- Keywords
- stroke triage, prehospital stroke, telestroke, ambulance, stroke code activation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telestroke triageOther
Live tele-neurologist consultation via the SMART Triage platform during ambulance assessment of suspected stroke.
Standard Care (in control arm)Other
Usual prehospital stroke triage according to RAV Hollands Midden protocols without telestroke consultation.
| Study group | Role | What they receive |
|---|---|---|
| Telestroke Triage + Standard Care | Experimental | Ambulance professionals receive real-time neurologist consultation via the SMART Triage platform in addition to standard prehospital stroke care. Receives: Other: Telestroke triage |
| Standard Care | Active comparator | RAV Hollands Midden triage protocol without telestroke consultation. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriate Patient Allocation
Proportion of patients allocated to the appropriate level of care, including comprehensive stroke center, primary stroke center, or home discharge when clinically appropriate.
Measured: Immediately after the prehospital triage decision
Unnecessary Stroke Code Activation
Proportion of ambulance-suspected stroke patients in whom stroke code activation leads to in-hospital stroke team activation and CT scan preparedness, while final work-up shows no stroke or no indication for immediate neuro-intervention.
Measured: Through initial emergency department stroke evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to telestroke triage plus standard care or standard care alone in a parallel-group design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 518 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nyika D. Kruyt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nyika D. Kruyt, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657117
- Sponsor's protocol ID
- N26.022
- Acronym
- ASTRAL
- Status last verified
- Sep 2026
- First submitted
- 5 Jun 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared. The shared dataset will include variables needed to reproduce the primary and secondary analyses, such as baseline characteristics, treatment allocation, primary and secondary outcome variables, and key analysis covariates. Direct identifiers will not be shared. Data will be coded and pseudonymized.
Publications
Duvekot MHC, Venema E, Rozeman AD, Moudrous W, Vermeij FH, Biekart M, Lingsma HF, Maasland L, Wijnhoud AD, Mulder LJMM, Alblas KCL, van Eijkelenburg RPJ, Buijck BI, Bakker J, Plaisier AS, Hensen JH, Lycklama A Nijeholt GJ, van Doormaal PJ, van Es ACGM, van der Lugt A, Kerkhoff H, Dippel DWJ, Roozenbeek B; PRESTO investigators. Comparison of eight prehospital stroke scales to detect intracranial large-vessel occlusion in suspected stroke (PRESTO): a prospective observational study. Lancet Neurol. 2021 Mar;20(3):213-221. doi: 10.1016/S1474-4422(20)30439-7. Epub 2021 Jan 7.
PubMed 33422191Brauckmann V, Hudasch D, Graff P, Riecke T, Aktas G, Mayor J, Macke C. Prehospital neurological emergencies- a survey on the state of prehospital neurological assessment by emergency medical professionals. BMC Emerg Med. 2024 Sep 11;24(1):164. doi: 10.1186/s12873-024-01076-w.
PubMed 39256650Nederlandse Vereniging voor Neurologie (NVN). Richtlijn Stroke 2021: Acute fase. Utrecht: NVN; 2021.
Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30.
PubMed 31662037
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulance Stroke Triage Assisted by Telemedicine (ASTRAL) Trial.
- ClinicalTrials.gov ID
- NCT07657117
- Acronym / sponsor ID
- ASTRAL / N26.022
- Conditions
- Stroke
- Keywords
- stroke triage, prehospital stroke, telestroke, ambulance, stroke code activation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 518 participants (estimated)
- Lead sponsor
- Nyika D. KruytUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 18 Jun 2026 (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.
The ASTRAL trial is a randomized study in patients with suspected stroke in the ambulance setting. The study evaluates whether prehospital telestroke consultation, in addition to standard care, can reduce unnecessary stroke code activations and improve patient triage, treatment efficiency, and resource use. Participants are randomized to telestroke triage plus standard care or standard care alone. Outcomes include unnecessary stroke code activation, patient allocation, treatment times, functional outcome, safety, and cost-effectiveness.
Detailed description
The Ambulance Stroke Triage Assisted by Telemedicine (ASTRAL) trial is a prospective, randomized controlled trial in suspected stroke patients attended by ambulance professionals in the RAV Hollands Midden region. Patients aged 18 years or older with stroke code activation during office hours and symptom onset within 24 hours are randomized 1:1 to telestroke triage plus standard care or standard care alone. The intervention consists of real-time video and audio consultation with an on-duty neurologist who advises on stroke probability, destination, and urgency of transport, while ambulance professionals retain final decision authority. The primary endpoint is unnecessary stroke code activation. Secondary endpoints include allocation accuracy, safety, door-to-needle and door-to-groin times, modified Rankin Scale at 3 months, health-related quality of life, healthcare utilization, stakeholder satisfaction, and cost-effectiveness. Outcome assessors for 3-month follow-up measures are blinded to allocation. Data are collected in Castor EDC, and analyses follow the intention-to-treat principle
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to telestroke triage plus standard care or standard care alone in a parallel-group design
| Arm | Type | Receives |
|---|---|---|
| Telestroke Triage + Standard Care | Experimental | Other: Telestroke triageAmbulance professionals receive real-time neurologist consultation via the SMART Triage platform in addition to standard prehospital stroke care. |
| Standard Care | Active comparator | Other: Standard Care (in control arm)RAV Hollands Midden triage protocol without telestroke consultation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Stroke code activation by ambulance professional during office hours
- Symptom onset < 24 hours or uncertain onset
- The patient is deemed capable of understanding the study information and making a decision about participation/opt-out
Key exclusion criteria (1 listed)
- Age under 18 years
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 |
|---|---|---|
| Telestroke triageLive tele-neurologist consultation via the SMART Triage platform during ambulance assessment of suspected stroke. | Other | Telestroke Triage + Standard Care |
| Standard Care (in control arm)Usual prehospital stroke triage according to RAV Hollands Midden protocols without telestroke consultation. | Other | Standard Care |
Primary outcome
Appropriate Patient Allocation
Time frame: Immediately after the prehospital triage decision
Proportion of patients allocated to the appropriate level of care, including comprehensive stroke center, primary stroke center, or home discharge when clinically appropriate.
Unnecessary Stroke Code Activation
Time frame: Through initial emergency department stroke evaluation
Proportion of ambulance-suspected stroke patients in whom stroke code activation leads to in-hospital stroke team activation and CT scan preparedness, while final work-up shows no stroke or no indication for immediate neuro-intervention.
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 18 Sep 2026.
- Background: PubMed 33422191Duvekot MHC, Venema E, Rozeman AD, Moudrous W, Vermeij FH, Biekart M, Lingsma HF, Maasland L, Wijnhoud AD, Mulder LJMM, Alblas KCL, van Eijkelenburg RPJ, Buijck BI, Bakker J, Plaisier AS, Hensen JH, Lycklama A Nijeholt GJ, van Doormaal PJ, van Es ACGM, van der Lugt A, Kerkhoff H, Dippel DWJ, Roozenbeek B; PRESTO investigators. Comparison of eight prehospital stroke scales to detect intracranial large-vessel occlusion in suspected stroke (PRESTO): a prospective observational study. Lancet Neurol. 2021 Mar;20(3):213-221. doi: 10.1016/S1474-4422(20)30439-7. Epub 2021 Jan 7.
- Background: PubMed 39256650Brauckmann V, Hudasch D, Graff P, Riecke T, Aktas G, Mayor J, Macke C. Prehospital neurological emergencies- a survey on the state of prehospital neurological assessment by emergency medical professionals. BMC Emerg Med. 2024 Sep 11;24(1):164. doi: 10.1186/s12873-024-01076-w.
- BackgroundNederlandse Vereniging voor Neurologie (NVN). Richtlijn Stroke 2021: Acute fase. Utrecht: NVN; 2021.
- Background: PubMed 31662037Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared. The shared dataset will include variables needed to reproduce the primary and secondary analyses, such as baseline characteristics, treatment allocation, primary and secondary outcome variables, and key analysis covariates. Direct identifiers will not be shared. Data will be coded and pseudonymized.
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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.
Robert Croese, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telestroke triage in people with Stroke, run by Nyika D. Kruyt at 1 site in Netherlands.
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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 18 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 Netherlands. 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 Nyika D Kruyt, PhD (+31 71 526 91 11, n.d.kruyt@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appropriate Patient Allocation (time frame: Immediately after the prehospital triage decision). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07657117, which also lists 4 linked publications.
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 18 Sep 2026.