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Improving Stroke Care in North-Norway Through Artificial Intelligence

Primary Purpose

Ischemic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
AI software StrokeSens (Circle NVI)
Sponsored by
University Hospital of North Norway
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ischemic Stroke focused on measuring Large vessel occlusion, Artificial intelligence, Thrombectomy, Interhospital transfer, Medium sized vessel occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Hospital of North NorwayRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

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

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

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of patients identified with LVO and MeVO in anterior circulation
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
Proportion of patients identified with LVO /MeVO treated with thrombectomy
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
Functional outcome at 90 days in patients with LVO/MeVO
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
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

Full Information

First Posted
June 5, 2023
Last Updated
August 28, 2023
Sponsor
University Hospital of North Norway
Collaborators
Nordlandssykehuset HF, Helgelandssykehuset HF, Finnmarkssykehuset HF, Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05903898
Brief Title
Improving Stroke Care in North-Norway Through Artificial Intelligence
Official Title
Improving Stroke Care in North-Norway Through Artificial Intelligence
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of North Norway
Collaborators
Nordlandssykehuset HF, Helgelandssykehuset HF, Finnmarkssykehuset HF, Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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: 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
Large vessel occlusion, Artificial intelligence, Thrombectomy, Interhospital transfer, Medium sized vessel occlusion

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients enrolled to a primary stroke center with access to AI-software image processing tool
Arm Type
Experimental
Arm Description
Patients enrolled to a primary stroke center with access to AI-software image processing tool to aid the radiologist in LVO and MeVO detection.
Arm Title
Patients enrolled to a primary stroke center without access to AI-software image processing tool
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
AI software StrokeSens (Circle NVI)
Intervention Description
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 Outcome Measure Information:
Title
Time interval from imaging completion to when a request for patient transfer is recorded
Description
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
Time Frame
Within 24 hours of stroke onset
Secondary Outcome Measure Information:
Title
Proportion of patients identified with LVO and MeVO in anterior circulation
Description
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
Time Frame
Within 24 hours of stroke onset
Title
Proportion of patients identified with LVO /MeVO treated with thrombectomy
Description
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
Time Frame
Within 24 hours of of stroke onset
Title
Functional outcome at 90 days in patients with LVO/MeVO
Description
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
Time Frame
90 (+/-14) days after stroke onset
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agnethe Eltoft, MD, PhD
Phone
004797193417
Email
agnethe.eltoft@unn.no
First Name & Middle Initial & Last Name or Official Title & Degree
Jon André Totland, MD
Email
Jon.Andre.Totland@unn.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnethe Eltoft
Organizational Affiliation
University Hospital of North Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of North Norway
City
Tromsø
ZIP/Postal Code
9038
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnethe Eltoft, MD, PhD
Phone
0097193417
Email
agnethe.eltoft@unn.no

12. IPD Sharing Statement

Learn more about this trial

Improving Stroke Care in North-Norway Through Artificial Intelligence

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