Acute Ischemic StrokeSMART-AINCT06645405
AI-Driven CTA Reconstruction for Intracranial LVO
A study testing AI algorithm in people with Acute Ischemic Stroke and Artificial Intelligence (AI), run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 2 sites in China.
Trial summary
Acute ischemic stroke (AIS) caused by intracranial large vessel occlusion (LVO) in the anterior circulation significantly contributes to stroke-related disability and mortality. Recent randomized controlled trials have demonstrated substantial benefits of endovascular thrombectomy (EVT) when patients are appropriately… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Acute Ischemic Stroke, Artificial Intelligence (AI), Endovascular Thrombectomy
- What is being tested?
- AI algorithm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 2 sitesChina
- Study dates
- 20 Oct 2024to 31 Dec 2025
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female, 18 years of age or older.
- Patients who present with signs and/or symptoms concerning acute ischemic stroke.
- Patients who undergo noncontrast CT and CT angiography imaging.
- Patients determined to have an intracranial large vessel occlusion (including the internal carotid artery, middle cerebral artery M1 segment, and M2 segment), and eligible for endovascular treatment.
Who cannot join
- 1) CT imaging with severe motion artifacts.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 1 recruiting
- Active, not recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
- Recruiting
Shanghai Sixth People's Hospital
Shanghai, 200023
Yueqi Zhu, MD, +86-21-66301136, zhuyueqi@hotmail.com
Yueqi Zhu, MD
About this study
Official title: Segmentation and Modeling for Accurate Reconstruction of CT Angiography of Intracranial Large Vessel Occlusion with Artificial Intelligence: a Stepped-wedge, Cluster-randomized Controlled Trial
Acute ischemic stroke (AIS) caused by intracranial large vessel occlusion (LVO) in the anterior circulation significantly contributes to stroke-related disability and mortality. Recent randomized controlled trials have demonstrated substantial benefits of endovascular thrombectomy (EVT) when patients are appropriately triaged beforehand. However, accurately orienting the 'missed segment' during EVT remains challenging. Guide-wires often fail to navigate through the occlusion or are mistakenly directed into the small tranches or even cause vessel rupture. To address this clinical need, the investigators developed an artificial intelligence (AI) algorithm to automate the reconstruction of CT angiography (CTA), focusing on the occluded LVO segment. To evaluate the clinical utility of this AI algorithm, the investigators propose a prospective, stepped-wedge cluster-randomized study to determine whether integrating our AI algorithm into AIS care flow can reduce the time for first pass of the thrombus by improving the visualization of the occluded segment on CTA. Physicians will assess patient eligibility for thrombectomy, and all selected patients will receive standard care according to current guidelines. This approach is expected to enhance patient treatment outcomes for endovascular thrombectomy by leveraging readily available data.
- Conditions
- Acute Ischemic Stroke, Artificial Intelligence (AI), Endovascular Thrombectomy, CT Angiography
- Being tested
- AI algorithm
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI algorithmBehavioural
Also called AI approach
Artificial intelligence algorithms in the automated reconstruction of intracranial large vessel occlusion (LVO)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No AI reconstruction |
| AI software | Experimental | An AI approach will be used for automated segmentation and reconstruction of CTA for intracranial LVO. Physicians begin to receive reconstructions and have the authority to view AI-activated images. Diagnosis and treatment decisions will be based on the clinical evaluation and review of the images by the treating physician, as per routine standard of care. Receives: Behavioral: AI algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
AFAT
The time from target angiography to the initiation of first thrombectomy attempt (angiography-to-first-attempt time [AFAT])
Measured: Immediately after EVT
Secondary outcomes (8)
PRT
The time from groin puncture to final arterial recanalization (puncture-to-recanalization time [PRT])
Measured: Immediately after EVT
IPT
The time from the completion of imaging to the initiation of EVT (imaging-to-puncture time [IPT])
Measured: Immediately after EVT
IRT
The time from imaging completion to final arterial recanalization (imaging-to-recanalization time [IRT])
Measured: Immediately after EVT
The rate of successful flow restoration immediately after EVT
The rate of successful flow restoration immediately after EVT
Measured: Immediately after EVT
The rate of symptomatic intracerebral hemorrhage within 24 hours post-EVT
The rate of symptomatic intracerebral hemorrhage within 24 hours post-EVT
Measured: 24 hours post-EVT
The rate of procedure-related complications
The rate of procedure-related complications
Measured: Immediately after EVT
The rate of functional independence at 90 days post-EVT
The rate of functional independence at 90 days post-EVT
Measured: 90 days post-EVT
The mortality rate within 90 days post-EVT
The mortality rate within 90 days post-EVT
Measured: 90 days post-EVT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start20 Oct 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yueqi Zhu, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645405
- Sponsor's protocol ID
- SMART-AI
- Acronym
- SMART-AI
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 16 Oct 2024
- 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 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Segmentation and Modeling for Accurate Reconstruction of CT Angiography of Intracranial Large Vessel Occlusion with Artificial Intelligence: a Stepped-wedge, Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06645405
- Acronym / sponsor ID
- SMART-AI / SMART-AI
- Conditions
- Acute Ischemic Stroke, Artificial Intelligence (AI), Endovascular Thrombectomy, CT Angiography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's HospitalUniversity, hospital or other
- Study start
- 20 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Oct 2024 (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.
Acute ischemic stroke (AIS) caused by intracranial large vessel occlusion (LVO) in the anterior circulation significantly contributes to stroke-related disability and mortality. Recent randomized controlled trials have demonstrated substantial benefits of endovascular thrombectomy (EVT) when patients are appropriately triaged beforehand. However, accurately orienting the 'missed segment' during EVT remains challenging. Guide-wires often fail to navigate through the occlusion or are mistakenly directed into the small tranches or even cause vessel rupture. To address this clinical need, the investigators developed an artificial intelligence (AI) algorithm to automate the reconstruction of CT angiography (CTA), focusing on the occluded LVO segment. To evaluate the clinical utility of this AI algorithm, the investigators propose a prospective, stepped-wedge cluster-randomized study to determine whether integrating our AI algorithm into AIS care flow can reduce the time for first pass of the thrombus by improving the visualization of the occluded segment on CTA. Physicians will assess patient eligibility for thrombectomy, and all selected patients will receive standard care according to current guidelines. This approach is expected to enhance patient treatment outcomes for endovascular thrombectomy by leveraging readily available data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No AI reconstruction |
| AI software | Experimental | Behavioral: AI algorithmAn AI approach will be used for automated segmentation and reconstruction of CTA for intracranial LVO. Physicians begin to receive reconstructions and have the authority to view AI-activated images. Diagnosis and treatment decisions will be based on the clinical evaluation and review of the images by the treating physician, as per routine standard of care. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or Female, 18 years of age or older.
- Patients who present with signs and/or symptoms concerning acute ischemic stroke.
- Patients who undergo noncontrast CT and CT angiography imaging.
- Patients determined to have an intracranial large vessel occlusion (including the internal carotid artery, middle cerebral artery M1 segment, and M2 segment), and eligible for endovascular treatment.
Key exclusion criteria (1 listed)
- 1) CT imaging with severe motion artifacts.
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 algorithmAlso: AI approachArtificial intelligence algorithms in the automated reconstruction of intracranial large vessel occlusion (LVO) | Behavioural | AI software |
Primary outcome
AFAT
Time frame: Immediately after EVT
The time from target angiography to the initiation of first thrombectomy attempt (angiography-to-first-attempt time [AFAT])
8 secondary outcomes
PRT
Time frame: Immediately after EVT
IPT
Time frame: Immediately after EVT
IRT
Time frame: Immediately after EVT
The rate of successful flow restoration immediately after EVT
Time frame: Immediately after EVT
The rate of symptomatic intracerebral hemorrhage within 24 hours post-EVT
Time frame: 24 hours post-EVT
The rate of procedure-related complications
Time frame: Immediately after EVT
The rate of functional independence at 90 days post-EVT
Time frame: 90 days post-EVT
The mortality rate within 90 days post-EVT
Time frame: 90 days post-EVT
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 16 Oct 2024.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI algorithm in people with Acute Ischemic Stroke and Artificial Intelligence (AI), run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 2 sites 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 4 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: looking for participants now, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Yueqi Zhu (+86-21-66301136, zhuyueqi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AFAT (time frame: Immediately after EVT). 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 16 Oct 2024.