NCT05903898

Improving Stroke Care in North-Norway Through Artificial Intelligence

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: University Hospital of North Norway · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
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 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 occlusions in the intracranial segment of the internal carotid artery and the proximal segments of the middle cerebral artery (MCA). Output to radiologists will be automated ASPECT scoring, automated search for LVO or MeVO.

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-10-31
• Completion: 2030-12-31
• First posted: 2023-06-15
• Last updated: 2025-07-23

Locations

1 site across 1 country: Norway