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Not yet recruitingNCT07892053PRESTOUpdated Oct 23, 2026

Prehospital Response and Emergency Stroke Transport Optimisation

An interventional study of Innovative pre-hospital emergency transport system for acute ischemic stroke in Acute Ischemic Stroke, sponsored by Xuanwu Hospital, Beijing. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Treatment

Updated Oct 23, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
320
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Acute Ischemic Stroke

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03

In context

Ischemic Stroke

2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.

This study's planned enrollment of 320 is above the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Xuanwu Hospital, Beijing is the lead sponsor of 357 studies on the registry; 226 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Hospitals:

  1. Hospitals with thrombolysis qualification and equipped with ambulances and pre-hospital emergency personnel.
  2. Pre-hospital emergency care can apply the AI-based innovative pre-hospital transport system.
  3. The hospital receives at least 60 stroke patients transferred via pre-hospital emergency and receiving intravenous thrombolysis annually.

Patients:

  1. Age ≥ 18 years.
  2. Suspected acute ischemic stroke patients.
  3. Symptom onset ≤ 4.5 hours.
  4. Arrival at the hospital via the pre-hospital emergency transport system.
  5. Signed informed consent.

Exclusion criteria

Exclusion Criteria:

Hospitals:

1. Hospitals participating in other research projects aimed at improving pre-hospital emergency processes or stroke thrombolysis treatment.

Patients:

  1. Patients who arrive at the hospital spontaneously (self-presentation).
  2. Patients deemed unsuitable for inclusion in the clinical trial by the investigators.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
320 participants (estimated)

Study arms

  • Other
    Group 1: Innovative pre-hospital transport system for 9 months

    Participants in this arm receive the innovative pre-hospital emergency transport system for 9 months.

    Behavioral: Innovative pre-hospital emergency transport system for acute ischemic stroke

  • Other
    Group 2: Innovative pre-hospital transport system for 6 months

    Participants in this arm receive the innovative pre-hospital emergency transport system for 6 months.

    Behavioral: Innovative pre-hospital emergency transport system for acute ischemic stroke

  • Other
    Group 3: Innovative pre-hospital transport system for 3 months

    Participants in this arm receive the innovative pre-hospital emergency transport system for 3 months.

    Behavioral: Innovative pre-hospital emergency transport system for acute ischemic stroke

Interventions

  • BehavioralInnovative pre-hospital emergency transport system for acute ischemic stroke

    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.

06

What researchers measure

Primary outcomes

  1. Door-to-Needle Time

    Time from hospital arrival to intravenous thrombolysis administration, measured in minutes.

    Time frame: Up to 24 hours after symptom onset or last known well.

Secondary outcomes

  1. Onset-to-Needle Time

    Time from symptom onset to intravenous thrombolysis administration, measured in minutes.

    Time frame: Up to 24 hours after symptom onset or last known well.

  2. Door-to-Imaging Time

    Time from hospital arrival to completion of neuroimaging (CT/MRI), measured in minutes.

    Time frame: Up to 24 hours after symptom onset or last known well.

  3. 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.

    Time frame: 72 ± 6 hours after hospital admission.

  4. 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.

    Time frame: At hospital discharge or 7 days after hospital admission, whichever occurs first.

  5. 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.

    Time frame: 90 days after hospital discharge

  6. Symptomatic Intracranial Hemorrhage

    Proportion of patients with symptomatic intracranial hemorrhage following intravenous thrombolysis, defined according to ECASS III criteria.

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

  7. All-Cause Mortality

    All-cause mortality rate at 90 days after hospital discharge.

    Time frame: 90 days after hospital discharge.

07

Study locations

1 site
  • Xuanwu Hospital Capital Medical University
    Beijing, 100053, China
    • Xuanwu Hospital Capital Medical University · Contact · m.qingfeng@163.com · +86010-83199086
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References and documents

Individual participant data

Plan to share: No — Due to the protection of participant privacy and institutional review board requirements, individual participant data (IPD) will not be shared publicly.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.

Of 569 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 12 months is below that.

Counting every sponsor, half of 652 studies reached it within 26 months; a quarter within 14 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 10, 2026
First posted
Oct 23, 2026
StartEst.
Oct 2026
Primary completionEst.
Oct 2027
CompletionEst.
Feb 2028
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07892053
Collaborators
Beijing Tiantan Hospital, The First Hospital of Hebei Medical University, The First Affiliated Hospital of Soochow University
Responsible party
qingfeng ma (Prof, Xuanwu Hospital, Beijing) — Principal investigator
First posted
Oct 23, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Feb 2028 (estimated)
Last update
Oct 23, 2026

Study contacts

Qingfeng Ma, Prof
Contact
m.qingfeng@163.com
+8615031041048
Zixin Wang, MD
Contact
wzx15031041048@163.com
+8615031041048
Qingfeng Ma, Prof
principal investigator · Xuanwu Hospital, Beijing

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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