NCT05903898

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
56mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress39%
Jun 2023Dec 2030

Study Start

First participant enrolled

June 1, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

2.4 years

First QC Date

June 5, 2023

Last Update Submit

July 18, 2025

Conditions

Ischemic Stroke

Keywords

Large vessel occlusionArtificial intelligenceThrombectomyInterhospital transferMedium sized vessel occlusion

Outcome Measures

Primary Outcomes (1)

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

    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

    Within 24 hours of stroke onset

Secondary Outcomes (4)

  • Proportion of patients identified with LVO and MeVO in anterior circulation

    Within 24 hours of stroke onset

  • Proportion of patients identified with LVO /MeVO treated with thrombectomy

    Within 24 hours of of stroke onset

  • Functional outcome at 90 days in patients with LVO/MeVO

    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

    Within 24 hours of of stroke onset

Study Arms (2)

Patients enrolled to a primary stroke center with access to AI-software image processing tool

EXPERIMENTAL

Patients enrolled to a primary stroke center with access to AI-software image processing tool to aid the radiologist in LVO and MeVO detection.

Device: AI software StrokeSens (Circle NVI)

Patients enrolled to a primary stroke center without access to AI-software image processing tool

NO INTERVENTION

Patients enrolled to a primary stroke center without access to AI-software image processing tool to aid the radiologist in LVO and MeVO detection (standard care).

Interventions

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.

Patients enrolled to a primary stroke center with access to AI-software image processing tool

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, 9038, Norway

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Agnethe Eltoft

    University Hospital of North Norway

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnethe Eltoft, MD, PhD

CONTACT

004797193417agnethe.eltoft@unn.no

Jon André Totland, MD

CONTACT

Jon.Andre.Totland@unn.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2023

First Posted

June 15, 2023

Study Start

June 1, 2023

Primary Completion

October 31, 2025

Study Completion (Estimated)

December 31, 2030

Last Updated

July 23, 2025

Record last verified: 2025-07

Locations

NO(1)