ClinicalTrials.gg
RecruitingNCT07785492Updated Aug 27, 2026

Artificial Intelligence Support for Stroke

An interventional study of AI-assisted thrombolysis decision support in Ischemic Stroke, Acute, sponsored by Capital Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Capital Medical University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
516
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 45 studies in Ischemic Stroke by Capital Medical University — 20 open to participants now, 25 under way, 10 of them phase 3. Ischemic Stroke · Capital Medical University.

Planned enrollment
10th of 39
516 · median 208
Started
2026
with 9 others
No phase
14 of 45
6 open now
Primary completion
2026-12
later than 11 of 24 live
Registered
44th of 45
by date

Among the 45 studies in Ischemic Stroke by Capital Medical University, this one is the 10th largest by planned enrollment of the 39 interventional ones that give a count, is one of 10 that started in 2026, is one of 14 with no phase, reaches primary completion later than 11 of the 24 other live ones, and was the 44th registered.

Ischemic Stroke

2,617 studies on the registry are indexed under Ischemic Stroke; 976 are open to participants now.

Browse Ischemic Stroke studies →

Open to participants now

20 of the 45 studies in Ischemic Stroke by Capital Medical University are open now, in 1 country. Recruiting first, the newest first:

14 more — sign in →

By country, each count listing its studies:

All 20 open studies →

Where they have run

Who these studies take

Of the 661 Ischemic Stroke studies recruiting now, 396 (60%) set no upper age limit and 62 (9%) stop at 75 or younger; 26 take children under 18; 42 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 45 studies in Ischemic Stroke by Capital Medical University, or all of them as a file.
02

Study summary

This study investigates whether an AI-assisted decision support tool, compared with standard care, increases the proportion of acute ischemic stroke patients receiving intravenous thrombolysis within 24 hours of symptom onset at a primary hospital in China, while also evaluating its impact on clinical outcomes, treatment timelines, and safety.

Read the detailed description

This single-center, randomized controlled, open-label, blinded-endpoint trial aims to evaluate whether an AI-assisted decision support tool increases the proportion of acute ischemic stroke patients (onset \<24 h) receiving intravenous thrombolysis at a primary hospital in China, and to assess its impact on clinical outcomes. Using cluster randomization at the level of attending physicians , the intervention group adds the AI tool to routine assessment, while the control group follows current guidelines and standard institutional protocols; both groups are not permitted to delay routine care for research purposes.

03

Conditions studied

  • Ischemic Stroke, Acute

Keywords

  • Randomized Controlled Trial
  • Stroke
  • AI
  • Thrombolysis
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

  1. Age ≥18 years.
  2. Clinical diagnosis of acute ischemic stroke.
  3. Onset time (last known well) \<24 hours.
  4. CT or MRI examination excluding intracerebral hemorrhage.
  5. Signed by the patient or a legally authorized representative

Exclusion criteria

Exclusion Criteria:

  1. Currently participating in another interventional clinical trial related to drugs or devices.
  2. Pregnant women.
  3. Has received intravenous thrombolysis at another hospital.
  4. Has completed a definitive reperfusion therapy decision at another hospital and is transferred to this hospital solely for follow-up observation or rehabilitation.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
516 participants (estimated)

Study arms

  • Experimental
    AI-Assisted Group

    Patients receive care from attending physicians who use the AI-assisted thrombolysis decision support tool in addition to routine assessment, with the final treatment decision left to the physician's clinical judgment.

    Other: AI-assisted thrombolysis decision support

  • No intervention
    Standard Treatment Group

    Patients receive standard acute ischemic stroke care according to the hospital's current protocols without the use of the AI tool.

Interventions

  • OtherAI-assisted thrombolysis decision support

    The AI-assisted thrombolysis decision support tool is used by attending physicians in addition to routine stroke evaluation. After the physician enters key patient data, the system generates real-time prompts on whether the patient meets criteria for intravenous thrombolysis, recommended additional tests and risk alerts for thrombolysis. The final treatment decision remains with the treating clinician.

06

What researchers measure

Primary outcomes

  1. The proportion of patients receiving intravenous thrombolysis.

    Time frame: 24 hours within last known well

Secondary outcomes

  1. Proportion of patients with an modified Rankin Scale score (the total score ranges from 0 to 6; a higher score indicates a more severe disability) of 0-1 at 90 days

    Time frame: 90 days after stroke onset

  2. 90-Day modified Rankin Scale score (the total score ranges from 0 to 6; a higher score indicates a more severe disability)

    Time frame: 90 days after stroke onset

  3. Early neurological improvement

    Defined as an improvement of at least 4 points on the National Institutes of Health Stroke Scale (NIHSS, 0-42 score, a higher score indicates a more severe condition) score within 24 hours, or a score of 0.

    Time frame: 24 hours after admission

  4. Time from admission to intravenous thrombolysis (DNT) in patients receiving intravenous thrombolysis

    Time frame: 24 hours within last known well

Other outcomes

  1. Proportion of symptomatic intracranial hemorrhage within 36 hours of thrombolysis

    Time frame: within 36 hours of thrombolysis

  2. Proportion of any type of intracranial hemorrhage within 36 hours of thrombolysis

    Time frame: within 36 hours of thrombolysis

  3. 90-day all-cause mortality rate.

    Time frame: 90 days after stroke onset

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking 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

Started Aug 2026 (actual). Primary completion is estimated for Dec 2026, 4 months after the start.

Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 4 months is below that.

Counting every sponsor, half of 653 studies reached it within 27 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
Aug 15, 2026
First posted
Aug 25, 2026
StartActual
Aug 26, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Mar 31, 2027
Last update
Aug 27, 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.
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07785492
Responsible party
Ji Xunming,MD,PhD (Professor of Neurology, Xuanwu Hospital, Capital Medical University, Capital Medical University) — Principal investigator
First posted
Aug 25, 2026
Start date
Aug 26, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Aug 27, 2026

Study contacts

Xunming Ji
Contact
jixm@ccmu.edu.cn
01083198962
Chuanjie Wu
Contact
wuchuanjie@ccmu.edu.cn
01083199439

Oversight

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

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