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
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.
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- 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.
- 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.