Improving Stroke Care in North-Norway Through Artificial Intelligence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI software StrokeSens (Circle NVI).
- Who it may be relevant to
- Registry conditions: Ischemic Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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).
Interventions
- Device AI software StrokeSens (Circle NVI)
Computed tomography (CT) and computed tomography angiography (CTA) imaging studies acquired upon admission will be assessed by the AI software StrokeSENS (Circle NVI). StrokeSENS is CE marked and available for clinical diagnostic purposes in the EU and UK.The software will be a decision support tool in addition to standard radiological services available in all primary stroke centers in Northern Norway where image interpretation is done by a radiologist or resident in radiology. The software can
Primary outcome measures
- Time interval from imaging completion to when a request for patient transfer is recorded [Time frame: Within 24 hours of stroke onset]
Secondary outcome measures (4)
- Proportion of patients identified with LVO and MeVO in anterior circulation [Time frame: Within 24 hours of stroke onset]
- Proportion of patients identified with LVO /MeVO treated with thrombectomy [Time frame: Within 24 hours of of stroke onset]
- Functional outcome at 90 days in patients with LVO/MeVO [Time frame: 90 (+/-14) days after stroke onset]
- 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 [Time frame: Within 24 hours of of stroke onset]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Norway · 1 center
- University Hospital of North Norway — Tromsø
Identifiers
NCT: NCT05903898 · 2022/24698(REK)