Ischemic Stroke, AcuteNCT07785492
Artificial Intelligence Support for Stroke
A study testing AI-assisted thrombolysis decision support in people with Ischemic Stroke, Acute, run by Capital Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Acute
- What is being tested?
- AI-assisted thrombolysis decision support
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 516 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- 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.
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, 1 recruiting
- Recruiting
Liuyang Jili Hospital
Changsha, Hunan
Yong He, 073183615622
About this study
Official title: 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.
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.
- Conditions
- Ischemic Stroke, Acute
- Being tested
- AI-assisted thrombolysis decision support
- Keywords
- Randomized Controlled Trial, Stroke, AI, Thrombolysis
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-assisted thrombolysis decision supportOther
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.
| Study group | Role | What they receive |
|---|---|---|
| AI-Assisted Group | Experimental | 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. Receives: Other: AI-assisted thrombolysis decision support |
| Standard Treatment Group | No intervention | Patients receive standard acute ischemic stroke care according to the hospital's current protocols without the use of the AI tool. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients receiving intravenous thrombolysis.
Measured: 24 hours within last known well
Secondary outcomes (4)
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
Measured: 90 days after stroke onset
90-Day modified Rankin Scale score (the total score ranges from 0 to 6; a higher score indicates a more severe disability)
Measured: 90 days after stroke onset
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.
Measured: 24 hours after admission
Time from admission to intravenous thrombolysis (DNT) in patients receiving intravenous thrombolysis
Measured: 24 hours within last known well
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start26 Aug 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 516 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785492
- Sponsor's protocol ID
- ASSIST
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-Assisted Decision Support for Intravenous Thrombolysis in Acute Ischemic Stroke at Basic Hospitals in China (ASSIST)
- ClinicalTrials.gov ID
- NCT07785492
- Acronym / sponsor ID
- ASSIST
- Conditions
- Ischemic Stroke, Acute
- Keywords
- Randomized Controlled Trial, Stroke, AI, Thrombolysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 516 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 26 Aug 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Assisted Group | Experimental | Other: AI-assisted thrombolysis decision supportPatients 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. |
| Standard Treatment Group | No intervention | –Patients receive standard acute ischemic stroke care according to the hospital's current protocols without the use of the AI tool. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-assisted thrombolysis decision supportThe 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. | Other | AI-Assisted Group |
Primary outcome
The proportion of patients receiving intravenous thrombolysis.
Time frame: 24 hours within last known well
4 secondary outcomes
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
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
Early neurological improvement
Time frame: 24 hours after admission
Time from admission to intravenous thrombolysis (DNT) in patients receiving intravenous thrombolysis
Time frame: 24 hours within last known well
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-assisted thrombolysis decision support in people with Ischemic Stroke, Acute, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xunming Ji (01083198962, jixm@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients receiving intravenous thrombolysis. (time frame: 24 hours within last known well). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.