Stroke, AcuteNCT05874596
Whole-process Quality Improvement of Endovascular Treatment Basd on an AI-aided Clinical Feedback System
A study testing AI-aided clinical feedback system coupled with multi-aspect intervention basd on Behaviour Change Wheel model in people with Stroke, Acute, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
A clustered randomized control trial to evaluate whether multi-aspect intervention based on an AI-aided clinical feedback system could improve the quality of EVT and functional outcome of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- AI-aided clinical feedback system coupled with multi-aspect intervention basd on Behaviour Change Wheel model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,289 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2024to 8 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- AIS patients receiving EVT within 24 hours of stroke onset
- Written informed consent is obtained
Who cannot join
- Patients refuse to participate in this study
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou
About this study
Official title: Whole-process Quality Improvement of Patients With Acute Ischemic Stroke Undergoing Endovascular Treatment Based on an Artificial Intelligence-aided Clinical Feedback System
A clustered randomized control trial to evaluate whether multi-aspect intervention based on an AI-aided clinical feedback system could improve the quality of EVT and functional outcome of patients.
Read the detailed description
Endovascular treatment (EVT) is the standard treatment for acute ischemic stroke (AIS) caused by large vessel occlusion (LVO) according to current guidelines. However, while a rapidly-growing number of stroke centers become capable of performing EVT, the general quality of EVT remains unsatisfied, resulting in a considerable proportion of patients who could not reach functional independence. Our pre-established artificial intelligence (AI)-aided clinical feedback system could dynamically record and report key timepoints of EVT in-hospital process. Combined with multi-aspect intervention via remote/on-site surveillance and education, this may be a potential solution for quality improvement of EVT. Therefore, the aim of the study is to evaluate whether an AI-aided clinical feedback system coupled with multi-aspect intervention could improve the quality of EVT. Twenty hospitals with annual EVT cases > 30 will be 1:1 randomized into intervention group and control group. The intervention group will receive AI-based clinical feedback system coupled with multi-aspect intervention, including remote/on-site surveillance and education regarding in-hospital workflow and surgical procedures of EVT. The control group only deploys AI-aided clinical feedback system. The primary outcome is the ratio of good functional outcome at 3 month.
- Conditions
- Stroke, Acute
- Being tested
- AI-aided clinical feedback system coupled with multi-aspect intervention basd on Behaviour Change Wheel model
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-aided clinical feedback system coupled with multi-aspect intervention basd on Behaviour Change Wheel modelBehavioural
Interventions are developed on a psychological model, the Behaviour Change Wheel (BCW) .The fundamental of BCW consists of three essential elements: capability, motivation, and opportunity. Improving individual's capability, providing motivation, and increasing opportunities are goals of behaviour change intervention. To achieve the goals, 9 intervention components have been proposed in the BCW framework, and 6 components will be used in current study.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | AI-aided clinical feedback system coupled with multi-aspect intervention based on the Behaviour Change Wheel model Receives: Behavioral: AI-aided clinical feedback system coupled with multi-aspect intervention basd on Behaviour Change Wheel model |
| Control | No intervention | AI-aided clinical feedback system only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of favorable functional outcome at 3 month
Ratio of patients with mRS ≤ 3 at 3-month follow up
Measured: 3 months
Secondary outcomes (10)
Ratio of good functional outcome at 3 month
Ratio of patients with mRS ≤2 at 3-month follow up
Measured: 3 months
mRS score at 3 month
mRS score at 3-month follow up
Measured: 3 months
Mortality at 3 month
Mortality at 3-month follow up
Measured: 3 months
Ratio of hemorrhagic transformation at 24 hour
Ratio of hemorrhagic transformation at 24 hour after EVT
Measured: 24 hours
Ratio of symptomatic intracranial hemorrhage at 24 hour
Ratio of symptomatic intracranial hemorrhage at 24 hour after EVT
Measured: 24 hours
Door to groin puncture time
Time interval between admission and groin puncture
Measured: 24 hours
Ratio of door to groin puncture time < 90 min
Time interval between admission and groin puncture <90 min
Measured: 24 hours
Ratio of door to groin puncture time < 60 min
Time interval between admission and groin puncture <60 min
Measured: 24 hours
Procedural duration
Time interval between groin puncture and last time of digital subtraction angiography
Measured: 24 hours
Ratio of successful reperfusion
Ratio of patients achieving modified thrombolysis in cerebral infarction (mTICI) 2b or 3
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start30 Jun 2024
- Primary completion5 Sep 2024
- Study completion8 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,289 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zexin Chen, Principal investigator, Ethics committee the second affiliated hospital, school of medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874596
- Sponsor's protocol ID
- OPTIMAL
- Status last verified
- Jul 2023
- First submitted
- 2 May 2023
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole-process Quality Improvement of Patients With Acute Ischemic Stroke Undergoing Endovascular Treatment Based on an Artificial Intelligence-aided Clinical Feedback System
- ClinicalTrials.gov ID
- NCT05874596
- Acronym / sponsor ID
- OPTIMAL
- Conditions
- Stroke, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,289 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 8 Dec 2024 (actual)
- First posted
- 25 May 2023 (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.
A clustered randomized control trial to evaluate whether multi-aspect intervention based on an AI-aided clinical feedback system could improve the quality of EVT and functional outcome of patients.
Detailed description
Endovascular treatment (EVT) is the standard treatment for acute ischemic stroke (AIS) caused by large vessel occlusion (LVO) according to current guidelines. However, while a rapidly-growing number of stroke centers become capable of performing EVT, the general quality of EVT remains unsatisfied, resulting in a considerable proportion of patients who could not reach functional independence. Our pre-established artificial intelligence (AI)-aided clinical feedback system could dynamically record and report key timepoints of EVT in-hospital process. Combined with multi-aspect intervention via remote/on-site surveillance and education, this may be a potential solution for quality improvement of EVT. Therefore, the aim of the study is to evaluate whether an AI-aided clinical feedback system coupled with multi-aspect intervention could improve the quality of EVT. Twenty hospitals with annual EVT cases > 30 will be 1:1 randomized into intervention group and control group. The intervention group will receive AI-based clinical feedback system coupled with multi-aspect intervention, including remote/on-site surveillance and education regarding in-hospital workflow and surgical procedures of EVT. The control group only deploys AI-aided clinical feedback system. The primary outcome is the ratio of good functional outcome at 3 month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: AI-aided clinical feedback system coupled with multi-aspect intervention basd on Behaviour Change Wheel modelAI-aided clinical feedback system coupled with multi-aspect intervention based on the Behaviour Change Wheel model |
| Control | No intervention | –AI-aided clinical feedback system only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18
- AIS patients receiving EVT within 24 hours of stroke onset
- Written informed consent is obtained
Key exclusion criteria (1 listed)
- Patients refuse to participate in this study
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-aided clinical feedback system coupled with multi-aspect intervention basd on Behaviour Change Wheel modelInterventions are developed on a psychological model, the Behaviour Change Wheel (BCW) .The fundamental of BCW consists of three essential elements: capability, motivation, and opportunity. Improving individual's capability, providing motivation, and increasing opportunities are goals of behaviour change intervention. To achieve the goals, 9 intervention components have been proposed in the BCW framework, and 6 components will be used in current study. | Behavioural | Intervention |
Primary outcome
Ratio of favorable functional outcome at 3 month
Time frame: 3 months
Ratio of patients with mRS ≤ 3 at 3-month follow up
10 secondary outcomes
Ratio of good functional outcome at 3 month
Time frame: 3 months
mRS score at 3 month
Time frame: 3 months
Mortality at 3 month
Time frame: 3 months
Ratio of hemorrhagic transformation at 24 hour
Time frame: 24 hours
Ratio of symptomatic intracranial hemorrhage at 24 hour
Time frame: 24 hours
Door to groin puncture time
Time frame: 24 hours
Ratio of door to groin puncture time < 90 min
Time frame: 24 hours
Ratio of door to groin puncture time < 60 min
Time frame: 24 hours
Procedural duration
Time frame: 24 hours
Ratio of successful reperfusion
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Zexin Chen principal investigator
Ethics committee the second affiliated hospital, school of medicine, Zhejiang University, China
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-aided clinical feedback system coupled with multi-aspect intervention basd on Behaviour Change Wheel model in people with Stroke, Acute, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 20 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of favorable functional outcome at 3 month (time frame: 3 months). 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 20 Nov 2025.