Acute Ischemic Stroke, Artificial Intelligence (AI), CT Angiography, Endovascular Thrombectomy
Conditions
Brief 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 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.
Interventions
BEHAVIORALAI algorithm
Artificial intelligence algorithms in the automated reconstruction of intracranial large vessel occlusion (LVO)
Sponsors
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
1. Male or Female, 18 years of age or older. 2. Patients who present with signs and/or symptoms concerning acute ischemic stroke. 3. Patients who undergo noncontrast CT and CT angiography imaging. 4. 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.
Exclusion criteria
1\) CT imaging with severe motion artifacts.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AFAT | Immediately after EVT | The time from target angiography to the initiation of first thrombectomy attempt (angiography-to-first-attempt time \[AFAT\]) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IPT | Immediately after EVT | The time from the completion of imaging to the initiation of EVT (imaging-to-puncture time \[IPT\]) |
| IRT | Immediately after EVT | The time from imaging completion to final arterial recanalization (imaging-to-recanalization time \[IRT\]) |
| The rate of successful flow restoration immediately after EVT | Immediately after EVT | The rate of successful flow restoration immediately after EVT |
| PRT | Immediately after EVT | The time from groin puncture to final arterial recanalization (puncture-to-recanalization time \[PRT\]) |
| The rate of procedure-related complications | Immediately after EVT | The rate of procedure-related complications |
| The rate of functional independence at 90 days post-EVT | 90 days post-EVT | The rate of functional independence at 90 days post-EVT |
| The mortality rate within 90 days post-EVT | 90 days post-EVT | The mortality rate within 90 days post-EVT |
| The rate of symptomatic intracerebral hemorrhage within 24 hours post-EVT | 24 hours post-EVT | The rate of symptomatic intracerebral hemorrhage within 24 hours post-EVT |
Countries
China
Contacts
Primary ContactYueqi Zhu
Outcome results
None listed