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NCT Number: NCT05903898

Improving Stroke Care in North-Norway Through Artificial Intelligence

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of North Norway

Tromsø, 9038, Norway

Location status: Recruiting

Location contact

Agnethe Eltoft, MD, PhD

CONTACT

[email protected]

0097193417

About this study

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:

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

The secondary goal is to evaluate:

  • If AI software leads to a higher number of thrombectomy treated LVO and MeVo patients.
  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

AI software StrokeSens (Circle NVI)

Device

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.

Primary outcomes

  1. Time interval from imaging completion to when a request for patient transfer is recorded

    Time frame: Within 24 hours of stroke onset

    The time interval from imaging to a received request for transfer to a comprehensive stroke centre by air ambulance or other means at centers with the use of AI software compared to centers with standard care

Secondary outcomes

  1. Proportion of patients identified with LVO and MeVO in anterior circulation

    Time frame: Within 24 hours of stroke onset

    Proportion of patients identified with large vessel occlusion and medium sized vessel occlusion in the anterior circulation on baseline CT angiography at centers with the use of AI software compared to centers with standard care

  2. Proportion of patients identified with LVO /MeVO treated with thrombectomy

    Time frame: Within 24 hours of of stroke onset

    Proportion of patients identified with large and medium vessel occlusion treated with thrombectomy at centers with the use of AI software compared to centers with standard care

  3. Functional outcome at 90 days in patients with LVO/MeVO

    Time frame: 90 (+/-14) days after stroke onset

    Functional outcome defined as modified Rankin scale (mRS) score 0-6 at 90 days post stroke at centers with the use of AI software compared to centers with standard care. The modified Rankin Scale (mRS) is a valid and reliable clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It is a scale used to measure functional recovery (the degree of disability or dependence in daily activities) of people who have suffered a stroke. mRS scores range from 0 (best outcome) to 6 (worst outcome), with 0 indicating no residual symptoms; 5 indicating bedbound, requiring constant care; and 6 indicating death

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Agnethe Eltoft, MD, PhD

CONTACT

[email protected]

004797193417

Jon André Totland, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • Finnmarkssykehuset HF
  • Helgeland Hospital Trust
  • Nordlandssykehuset HF
  • Oslo University Hospital

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2030
First posted
Jun 15, 2023
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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