Acute Ischemic StrokePRESTONCT07892053
Prehospital Response and Emergency Stroke Transport Optimisation
A study testing Innovative pre-hospital emergency transport system for acute ischemic stroke in people with Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This study aims to develop and evaluate an innovative prehospital emergency transport system for patients with acute ischemic stroke to reduce delays in reperfusion treatment. The system integrates artificial intelligence-based prehospital stroke assessment, selected examinations and blood collection in the ambulance… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Innovative pre-hospital emergency transport system for acute ischemic stroke
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Feb 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
- Hospitals：
- Hospitals with thrombolysis qualification and equipped with ambulances and pre-hospital emergency personnel.
- Pre-hospital emergency care can apply the AI-based innovative pre-hospital transport system.
- The hospital receives at least 60 stroke patients transferred via pre-hospital emergency and receiving intravenous thrombolysis annually.
- Patients：
- Age ≥ 18 years.
Show all 10Show fewer
- Suspected acute ischemic stroke patients.
- Symptom onset ≤ 4.5 hours.
- Arrival at the hospital via the pre-hospital emergency transport system.
- Signed informed consent.
Who cannot join
- Hospitals：
- 1. Hospitals participating in other research projects aimed at improving pre-hospital emergency processes or stroke thrombolysis treatment.
- Patients：
- Patients who arrive at the hospital spontaneously (self-presentation).
- Patients deemed unsuitable for inclusion in the clinical trial by the investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xuanwu Hospital Capital Medical University
Beijing, 100053
Xuanwu Hospital Capital Medical University, +86010-83199086, m.qingfeng@163.com
About this study
Official title: Prehospital Response and Emergency Stroke Transport Optimisation: A Multicentre, Stepped-Wedge Cluster-Randomized Clinical Trial
This study aims to develop and evaluate an innovative prehospital emergency transport system for patients with acute ischemic stroke to reduce delays in reperfusion treatment. The system integrates artificial intelligence-based prehospital stroke assessment, selected examinations and blood collection in the ambulance, and real-time information sharing between emergency medical services and the receiving hospital. Its effectiveness will be evaluated in a multicenter, stepped-wedge cluster randomized controlled trial comparing the innovative system with standard prehospital care. The primary outcome is the time from hospital arrival to intravenous thrombolysis.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Innovative pre-hospital emergency transport system for acute ischemic stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innovative pre-hospital emergency transport system for acute ischemic strokeBehavioural
The system includes an AI-based pre-hospital stroke assessment tool (e.g., G-FAST score), rapid blood glucose testing, pre-hospital blood draws, ECG testing, and pre-thrombolysis informed consent. Real-time information sharing between the ambulance and the hospital is implemented to ensure coordinated care. All participants also receive standard in-hospital stroke evaluation and treatment.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Innovative pre-hospital transport system for 9 months | Other | Participants in this arm receive the innovative pre-hospital emergency transport system for 9 months. Receives: Behavioral: Innovative pre-hospital emergency transport system for acute ischemic stroke |
| Group 2: Innovative pre-hospital transport system for 6 months | Other | Participants in this arm receive the innovative pre-hospital emergency transport system for 6 months. Receives: Behavioral: Innovative pre-hospital emergency transport system for acute ischemic stroke |
| Group 3: Innovative pre-hospital transport system for 3 months | Other | Participants in this arm receive the innovative pre-hospital emergency transport system for 3 months. Receives: Behavioral: Innovative pre-hospital emergency transport system for acute ischemic stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Door-to-Needle Time
Time from hospital arrival to intravenous thrombolysis administration, measured in minutes.
Measured: Up to 24 hours after symptom onset or last known well.
Secondary outcomes (7)
Onset-to-Needle Time
Time from symptom onset to intravenous thrombolysis administration, measured in minutes.
Measured: Up to 24 hours after symptom onset or last known well.
Door-to-Imaging Time
Time from hospital arrival to completion of neuroimaging (CT/MRI), measured in minutes.
Measured: Up to 24 hours after symptom onset or last known well.
72-Hour National Institutes of Health Stroke Scale Score
The National Institutes of Health Stroke Scale (NIHSS) assesses neurological impairment. Scores range from 0 to 42, with higher scores indicating more severe neurological deficits and a worse neurological status.
Measured: 72 ± 6 hours after hospital admission.
National Institutes of Health Stroke Scale Score at Discharge or Day 7
The National Institutes of Health Stroke Scale (NIHSS) assesses neurological impairment. Scores range from 0 to 42, with higher scores indicating more severe neurological deficits and a worse neurological status.
Measured: At hospital discharge or 7 days after hospital admission, whichever occurs first.
90-Day modified Rankin Scale Score
The distribution of modified Rankin Scale score at 90 days, on which scores range from 0 (no neurologic deficit) to 6 (death), with higher scores indicating greater disability and a worse functional outcome.
Measured: 90 days after hospital discharge
Symptomatic Intracranial Hemorrhage
Proportion of patients with symptomatic intracranial hemorrhage following intravenous thrombolysis, defined according to ECASS III criteria.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
All-Cause Mortality
All-cause mortality rate at 90 days after hospital discharge.
Measured: 90 days after hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, The First Hospital of Hebei Medical University, The First Affiliated Hospital of Soochow University
- Responsible party
- Principal investigator, qingfeng ma, Xuanwu Hospital, Beijing
- Investigators
- Qingfeng Ma, Prof, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892053
- Sponsor's protocol ID
- PRESTO
- Acronym
- PRESTO
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the protection of participant privacy and institutional review board requirements, individual participant data (IPD) will not be shared publicly.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehospital Response and Emergency Stroke Transport Optimisation: A Multicentre, Stepped-Wedge Cluster-Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07892053
- Acronym / sponsor ID
- PRESTO / PRESTO
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, The First Hospital of Hebei Medical University, The First Affiliated Hospital of Soochow University
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 23 Oct 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.
This study aims to develop and evaluate an innovative prehospital emergency transport system for patients with acute ischemic stroke to reduce delays in reperfusion treatment. The system integrates artificial intelligence-based prehospital stroke assessment, selected examinations and blood collection in the ambulance, and real-time information sharing between emergency medical services and the receiving hospital. Its effectiveness will be evaluated in a multicenter, stepped-wedge cluster randomized controlled trial comparing the innovative system with standard prehospital care. The primary outcome is the time from hospital arrival to intravenous thrombolysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Innovative pre-hospital transport system for 9 months | Other | Behavioral: Innovative pre-hospital emergency transport system for acute ischemic strokeParticipants in this arm receive the innovative pre-hospital emergency transport system for 9 months. |
| Group 2: Innovative pre-hospital transport system for 6 months | Other | Behavioral: Innovative pre-hospital emergency transport system for acute ischemic strokeParticipants in this arm receive the innovative pre-hospital emergency transport system for 6 months. |
| Group 3: Innovative pre-hospital transport system for 3 months | Other | Behavioral: Innovative pre-hospital emergency transport system for acute ischemic strokeParticipants in this arm receive the innovative pre-hospital emergency transport system for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Hospitals：
- Hospitals with thrombolysis qualification and equipped with ambulances and pre-hospital emergency personnel.
- Pre-hospital emergency care can apply the AI-based innovative pre-hospital transport system.
- The hospital receives at least 60 stroke patients transferred via pre-hospital emergency and receiving intravenous thrombolysis annually.
- Patients：
Key exclusion criteria (5 listed)
- Hospitals：
- 1. Hospitals participating in other research projects aimed at improving pre-hospital emergency processes or stroke thrombolysis treatment.
- Patients：
- Patients who arrive at the hospital spontaneously (self-presentation).
- Patients deemed unsuitable for inclusion in the clinical trial by the investigators.
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 |
|---|---|---|
| Innovative pre-hospital emergency transport system for acute ischemic strokeThe system includes an AI-based pre-hospital stroke assessment tool (e.g., G-FAST score), rapid blood glucose testing, pre-hospital blood draws, ECG testing, and pre-thrombolysis informed consent. Real-time information sharing between the ambulance and the hospital is implemented to ensure coordinated care. All participants also receive standard in-hospital stroke evaluation and treatment. | Behavioural | Group 1: Innovative pre-hospital transport system for 9 months, Group 2: Innovative pre-hospital transport system for 6 months, Group 3: Innovative pre-hospital transport system for 3 months |
Primary outcome
Door-to-Needle Time
Time frame: Up to 24 hours after symptom onset or last known well.
Time from hospital arrival to intravenous thrombolysis administration, measured in minutes.
7 secondary outcomes
Onset-to-Needle Time
Time frame: Up to 24 hours after symptom onset or last known well.
Door-to-Imaging Time
Time frame: Up to 24 hours after symptom onset or last known well.
72-Hour National Institutes of Health Stroke Scale Score
Time frame: 72 ± 6 hours after hospital admission.
National Institutes of Health Stroke Scale Score at Discharge or Day 7
Time frame: At hospital discharge or 7 days after hospital admission, whichever occurs first.
90-Day modified Rankin Scale Score
Time frame: 90 days after hospital discharge
Symptomatic Intracranial Hemorrhage
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
All-Cause Mortality
Time frame: 90 days after hospital discharge.
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 23 Oct 2026.
- Individual participant dataSharing planned: No. Due to the protection of participant privacy and institutional review board requirements, individual participant data (IPD) will not be shared publicly.
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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.
Qingfeng Ma, Prof principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Innovative pre-hospital emergency transport system for acute ischemic stroke in people with Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing at 1 site in China.
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 10 inclusion and 5 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 23 Oct 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 China. 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 Qingfeng Ma, Prof (+8615031041048, m.qingfeng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Door-to-Needle Time (time frame: Up to 24 hours after symptom onset or last known well.). 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 23 Oct 2026.