Artificial Intelligence Support for Stroke
26. august 2026 opdateret af: Ji Xunming,MD,PhD, Capital Medical University
Artificial Intelligence-Assisted Decision Support for Intravenous Thrombolysis in Acute Ischemic Stroke at Basic Hospitals in China (ASSIST)
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
516
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Xunming Ji
- Telefonnummer: 01083198962
- E-mail: jixm@ccmu.edu.cn
Undersøgelse Kontakt Backup
- Navn: Chuanjie Wu
- Telefonnummer: 01083199439
- E-mail: wuchuanjie@ccmu.edu.cn
Studiesteder
-
-
Hunan
-
Changsha, Hunan, Kina
- Rekruttering
- Liuyang Jili Hospital
-
Kontakt:
- Yong He
- Telefonnummer: 073183615622
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Age ≥18 years.
- Clinical diagnosis of acute ischemic stroke.
- Onset time (last known well) <24 hours.
- CT or MRI examination excluding intracerebral hemorrhage.
- Signed informed consent by the patient or a legally authorized representative
Exclusion Criteria:
- Currently participating in another interventional clinical trial related to drugs or devices.
- Pregnant women.
- Has received intravenous thrombolysis at another hospital.
- Has completed a definitive reperfusion therapy decision at another hospital and is transferred to this hospital solely for follow-up observation or rehabilitation.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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.
|
|
Ingen indgriben: Standard Treatment Group
Patients receive standard acute ischemic stroke care according to the hospital's current protocols without the use of the AI tool.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The proportion of patients receiving intravenous thrombolysis.
Tidsramme: 24 hours within last known well
|
24 hours within last known well
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
Tidsramme: 90 days after stroke onset
|
90 days after stroke onset
|
|
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90-Day modified Rankin Scale score (the total score ranges from 0 to 6; a higher score indicates a more severe disability)
Tidsramme: 90 days after stroke onset
|
90 days after stroke onset
|
|
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Early neurological improvement
Tidsramme: 24 hours after admission
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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.
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24 hours after admission
|
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Time from admission to intravenous thrombolysis (DNT) in patients receiving intravenous thrombolysis
Tidsramme: 24 hours within last known well
|
24 hours within last known well
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Proportion of symptomatic intracranial hemorrhage within 36 hours of thrombolysis
Tidsramme: within 36 hours of thrombolysis
|
within 36 hours of thrombolysis
|
|
Proportion of any type of intracranial hemorrhage within 36 hours of thrombolysis
Tidsramme: within 36 hours of thrombolysis
|
within 36 hours of thrombolysis
|
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90-day all-cause mortality rate.
Tidsramme: 90 days after stroke onset
|
90 days after stroke onset
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
26. august 2026
Primær færdiggørelse (Anslået)
31. december 2026
Studieafslutning (Anslået)
31. marts 2027
Datoer for studieregistrering
Først indsendt
15. august 2026
Først indsendt, der opfyldte QC-kriterier
23. august 2026
Først opslået (Faktiske)
25. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ASSIST
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