Clinical trial NCT05903898: Improving Stroke Care in North-Norway Through Artificial Intelligence
Official title: Improving Stroke Care in North-Norway Through Artificial Intelligence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Keywords: Large vessel occlusion
Artificial intelligence
Thrombectomy
Interhospital transfer
Medium sized vessel occlusion
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: Nordlandssykehuset HF
name: Helgeland Hospital Trust
name: Finnmarkssykehuset HF
name: Oslo University Hospital
First posted: 2023-06-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Prospective observational multi-center intervention study. The study aims to evaluate whether an artificial intelligence (AI) support tool for radiological image processing (StrokeSens, Circle NVI) can accelerate decision making and increase detection rate in patients with an acute ischemic stroke caused by intracranial large vessel occlusion (LVO) or medium vessel occlusion (MeVO) in Northern Norway. Relevant outcomes will be compared between centres with and without available software during the study period.

Detailed description: This study aims to evaluate whether an AI support tool (StrokeSens, Circle NVI) can accelerate decision making and increase detection rate in patients with an acute ischemic stroke caused by intracranial large vessel occlusion (LVO) or medium vessel occlusion (MeVO) in Northern Norway. The software will be a decision support tool in addition to standard radiological services where image interpretation is done by a radiologist or resident in radiology. The AI-tool will be available in 5 of 10 primary hospitals in Northern Norway. The AI-software employed in this study can automatically evaluate the presence of ischemic changes in the vascular territory of the middle cerebral artery according to the Alberta Stroke Program Early CT Score (ASPECTS) and detect occlusions in the intracranial segment of the internal carotid artery and the proximal segments of the middle cerebral artery (MCA).

The main goal of this project is to evaluate if access to the AI-software:

1. Accelerates identification and handling of stroke patients harbouring an intracranial LVO.
2. Leads to a higher detection rate of anterior circulation LVO and MeVO.

The secondary goal is to evaluate:

1. If AI software leads to a higher number of thrombectomy treated LVO and MeVo patients.
2. If AI software may lead to improved patient outcomes.

Hypothesis: Implementation of AI-based image analysis software as a decision support tool for radiologists, reduces time from imaging to transfer request in patients harbouring LVO/MeVO, and increases detection rate of large and medium sized vessel intracranial occlusion compared to the present day practices in primary stroke centres within the health region.

All outcomes will be a compared between primary stroke centres with and without access to the AI-software and historical data from the same sites as collected prior to software implementation (2019-2022).

Eligibility criteria: Inclusion Criteria:

* Patients with acute stroke symptoms admitted to a participating hospital within 24 hours of symptom onset

Exclusion Criteria:

* Patients not available for follow-up assessments (e.g. non-resident)

Primary outcomes:
measure: Time interval from imaging completion to when a request for patient transfer is recorded
timeFrame: Within 24 hours of stroke onset
Secondary outcomes:
measure: Proportion of patients identified with LVO and MeVO in anterior circulation
timeFrame: Within 24 hours of stroke onset
measure: Proportion of patients identified with LVO /MeVO treated with thrombectomy
timeFrame: Within 24 hours of of stroke onset
measure: Functional outcome at 90 days in patients with LVO/MeVO
timeFrame: 90 (+/-14) days after stroke onset
measure: Time from symptom onset to start of thrombectomy in patients identified with LVO and medium vessel occlusion at centers with the use of AI software compared to centers with standard care
timeFrame: Within 24 hours of of stroke onset
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: University Hospital of North Norway
name: Agnethe Eltoft
role: PRINCIPAL_INVESTIGATOR
References: