Prehospital Response and Emergency Stroke Transport Optimisation
PRESTO
1 other identifier
interventional
320
1 country
1
Brief 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, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2026
CompletedFirst Submitted
Initial submission to the registry
October 10, 2026
CompletedFirst Posted
Study publicly available on registry
October 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
October 23, 2026
October 1, 2026
1 year
October 10, 2026
October 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Door-to-Needle Time
Time from hospital arrival to intravenous thrombolysis administration, measured in minutes.
Up to 24 hours after symptom onset or last known well.
Secondary Outcomes (7)
Onset-to-Needle Time
Up to 24 hours after symptom onset or last known well.
Door-to-Imaging Time
Up to 24 hours after symptom onset or last known well.
72-Hour National Institutes of Health Stroke Scale Score
72 ± 6 hours after hospital admission.
National Institutes of Health Stroke Scale Score at Discharge or Day 7
At hospital discharge or 7 days after hospital admission, whichever occurs first.
90-Day modified Rankin Scale Score
90 days after hospital discharge
- +2 more secondary outcomes
Study Arms (3)
Group 1: Innovative pre-hospital transport system for 9 months
OTHERParticipants in this arm receive the innovative pre-hospital emergency transport system for 9 months.
Group 2: Innovative pre-hospital transport system for 6 months
OTHERParticipants in this arm receive the innovative pre-hospital emergency transport system for 6 months.
Group 3: Innovative pre-hospital transport system for 3 months
OTHERParticipants in this arm receive the innovative pre-hospital emergency transport system for 3 months.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
- Suspected acute ischemic stroke patients.
- Symptom onset ≤ 4.5 hours.
- Arrival at the hospital via the pre-hospital emergency transport system.
- Signed informed consent.
You may not qualify if:
- Hospitals：
- \. 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xuanwu Hospital, Beijinglead
- Beijing Tiantan Hospitalcollaborator
- The First Hospital of Hebei Medical Universitycollaborator
- The First Affiliated Hospital of Soochow Universitycollaborator
Study Sites (1)
Xuanwu Hospital Capital Medical University
Beijing, 100053, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qingfeng Ma, Prof
Xuanwu Hospital, Beijing
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
October 10, 2026
First Posted
October 23, 2026
Study Start
October 1, 2026
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
February 1, 2028
Last Updated
October 23, 2026
Record last verified: 2026-10
Data Sharing
- IPD Sharing
- Will not share
Due to the protection of participant privacy and institutional review board requirements, individual participant data (IPD) will not be shared publicly.