Improving Stroke Care in North-Norway Through Artificial Intelligence
ConditionIschemic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital of North Norway
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with acute stroke symptoms admitted to a participating hospital within 24 hours of symptom onset
Disqualifiers
Patients not available for follow-up assessments (e.g. non-resident)
Trial design
Design model
Parallel
Treatments tested in this trial
AI software StrokeSens (Circle NVI)
DeviceComputed 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.
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Patients enrolled to a primary stroke center with access to AI-software image processing toolExperimental treatment 1 intervention
Group B: Patients enrolled to a primary stroke center without access to AI-software image processing toolNo intervention 0 interventions
Trial outcomes
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
Time frame
Within 24 hours of stroke onsetSecondary outcomes
1
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
Time frame
Within 24 hours of stroke onset2
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
Time frame
Within 24 hours of of stroke onset3
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 frame
90 (+/-14) days after stroke onset4
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 onsetSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital of North Norway
Lead sponsor
Nordlandssykehuset HF
Collaborator
Helgeland Hospital Trust
Collaborator
Finnmarkssykehuset HF
Collaborator
Oslo University Hospital
Collaborator
Source ClinicalTrials.gov