StrokeAID-STROKENCT07390708
Artificial Intelligence-Assisted Magnetic Resonance Imaging Diagnostic Strategy in a Tertiary Stroke Center
An observational study of Stroke and Stroke Assessment, run by Aarhus University Hospital at 2 sites in Denmark.
Trial summary
Quality improvement study with prospective observational design. The study monitors the diagnostic accuracy of an AI-assisted resident radiologist-termed the AI-ResRad diagnostic strategy-compared to an on-call specialist neuroradiologist-termed the SpecNeuroRad strategy-in interpreting stroke MRIs in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Stroke Assessment
- What is being tested?
- Index test (AI-ResRad), Reference test (SpecNeuroRad) and Comparative Index tests: ResRad and AI-SpecNeuroRad
- Type of treatment
- Pill or oral medicine
- How many people
- 15 participants
- Where
- 2 sitesDenmark
- Study dates
- 16 Feb 2026to 1 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients suspected of stroke with known onset who meet the rapid response stroke activation and MRI criteria at Aarhus University Hospital and Gødstrup Regional Hospital will be included consecutively.
Who may be able to join
- Age ≥ 18 years
- Stroke team activation
- Thrombolysis candidate
- Known symptom onset
- MRI candidate
Who cannot join
- Prior inclusion
- Previous MRI in the same course of hospitalization
- No resident radiologist on call
- Participation in the neurologists' sub-study is limited to participants enrolled at one of the two participating sites at Gødstrup Regional Hospital.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University Hospital
Aarhus, 8200
Gødstrup Regional Hospital
Gødstrup
About this study
Official title: An Artificial Intelligence-Assisted Magnetic Resonance Imaging Diagnostic Strategy in a Tertiary Stroke Center-a Diagnostic Accuracy Study
Quality improvement study with prospective observational design. The study monitors the diagnostic accuracy of an AI-assisted resident radiologist-termed the AI-ResRad diagnostic strategy-compared to an on-call specialist neuroradiologist-termed the SpecNeuroRad strategy-in interpreting stroke MRIs in patients with known onset.
The study includes a pre-planned sub-study evaluating the diagnostic accuracy of neurologists and AI-assisted neurologists.
Read the detailed description
Current clinical practice and the supporting evidence base rely on interpretations by specialist neuroradiologists. Modern radiology departments face increasing imaging demands while contending with limited resources-including a shortage of specialist neuroradiologists. In the ideal setting, patients are evaluated in real time by a vascular neurologist and a neuroradiologist, who synchronously integrate clinical and imaging findings. In such cases, thrombolysis decisions can be re-evaluated concurrently with MRI acquisition, initiating treatment within minutes of scan completion. Although modern stroke MRI protocols can be completed in as little as 10 minutes, these rapid-response team activations often consume a disproportionate share of specialist time and availability. Consequently, real-world clinical practice frequently involves alternative team configurations, including resident radiologists, resident neurologists, and remote specialist consultations-compositions that vary depending on the on-call team's experience, time of day, and day of the week.
Artificial intelligence (AI) can support the team with image interpretation, potentially optimizing time and resources. Recent studies have explored the role of AI-assisted stroke workflows and its ability to accurately detect ischemic lesions and hemorrhagic stroke-demonstrating promising encouraging diagnostic performance. However, there remains a need for prospective studies evaluating the real-world diagnostic accuracy of AI assistance as applied within its intended clinical use context To further understand the potential contributions of AI-assistance and resident radiologist interpretations, we designed the AID-STROKE accuracy study, under the Danish Quality Improvement legal and design framework.
Sub-study: An Artificial Intelligence-Assisted Neurologist-based Diagnostic Strategy in Magnetic Resonance Imaging of Acute Stroke Patients with Known Onset-a Diagnostic Accuracy Study
This pre-specified sub-study will be conducted in patients received at one of the hospitals (Gødstrup Regional Hospital)
- Conditions
- Stroke, Stroke Assessment
- Being tested
- Index test (AI-ResRad), Reference test (SpecNeuroRad), Comparative Index tests: ResRad and AI-SpecNeuroRad, Neurologist Diagnostic Accuracy (Sub-study outcome)
- Keywords
- stroke, MRI, Artificial Intelligence
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Index test (AI-ResRad)Diagnostic test
Eligible residents will review MRI sequences from the local PACS as they become available. During this process, they will maintain real-time communication-in person or via phone-with the treating neurologist, who will provide relevant clinical information. Simultaneously, the resident will have access to the AI output. Residents will have full access to the patient's electronic medical record and prior imaging. After integrating these inputs, the resident will complete an AI-assisted MRI interpretation using a predefined survey structure.
Reference test (SpecNeuroRad)Diagnostic test
Before any MRI sequences have been finalized, the resident will notify the on-call specialist neuroradiologist and pass on the clinical information received from the neurologist. The neuroradiologist will then independently review the MRI sequences as they become available in PACS, without access to the resident's interpretation or the AI results. They will also access the patient's electronic medical record and prior imaging. Once both parties have completed their respective surveys, the resident will call the neuroradiologist to jointly deliver an oral MRI interpretation to the neurologist. The radiologic information system's written radiology report may be completed by the neuroradiologist or the resident, with final sign-off by the neuroradiologist.
Comparative Index tests: ResRad and AI-SpecNeuroRadDiagnostic test
Two additional comparative test strategies will be evaluated:
- ResRad: Prior to accessing AI results, residents will complete a non-assisted MRI interpretation.
- AI-SpecNeuroRad: After completing their initial non-assisted interpretation (SpecNeuroRad), the specialist neuroradiologist will be granted access to the AI output. They will then submit a second interpretation (AI-assisted) using the same survey platform.
To enforce internal blinding between non-assisted and AI-assisted interpretations, AI outputs are only revealed upon manual activation, which is timestamped by the system. Interpretation surveys are also timestamped at submission. All non-assisted interpretations must be submitted prior to AI output activation to be considered valid. Cases that violate this timestamp sequence will be excluded from final analyses to ensure methodological integrity.
Neurologist Diagnostic Accuracy (Sub-study outcome)Diagnostic test
Simultaneously with the radiologists' MRI interpretations with and without AI assistance according to the study workflow, the neurologist responsible for patient management will complete a similar MRI interpretation survey. The neurologist will first interpret the MRI without AI assistance and subsequently with AI assistance, mirroring the radiologist study workflow. The neurologist will be blinded to the radiologists' interpretations while completing their assessments, and likewise, the radiologists will be blinded to the neurologist's interpretations.
| Study group | Role | What they receive |
|---|---|---|
| Acute stroke with known onset | Adult patients suspected of stroke with known onset who meet the rapid response stroke activation and MRI criteria at Aarhus University Hospital and Gødstrup Regional Hospital will be included consecutively. Receives: Diagnostic Test: Index test (AI-ResRad); Diagnostic Test: Reference test (SpecNeuroRad); Diagnostic Test: Comparative Index tests: ResRad and AI-SpecNeuroRad; Diagnostic Test: Neurologist Diagnostic Accuracy (Sub-study outcome) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite agreement
Overall agreement is defined as the proportion of patients for whom the AI-ResRad and SpecNeuroRad agree on all MRI pattern items included in the MRI interpretation survey: (1) DWI lesion and (2) hemorrhage.
Measured: Immediately after the procedure
Secondary outcomes (3)
Diagnostic Accuracy
The diagnostic accuracy of the AI-ResRad and ResRad strategies will be reported in terms of sensitivity, specificity, and positive and negative predictive values, using SpecNeuroRad as the reference standard. This will be assessed separately for each of the imaging patterns: 1) DWI lesion; and 2) hemorrhage.
Measured: immediately after the procedure
Comparative Diagnostic Accuracy
Comparative diagnostic accuracy outcomes will be explored between the AI-ResRad and ResRad strategies, using SpecNeuroRad as the reference standard, including the net reclassification index, net benefit, and absolute difference in overall agreement (defined as described above for the primary outcome).
Measured: immediately after the procedure
Concordance SpecNeuroRad
For the AI-SpecNeuroRad strategy, outcomes will include pairwise agreement with the original SpecNeuroRad interpretation, characterization of disagreement cases, and identification of AI-induced reclassifications.
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start16 Feb 2026
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Why it stopped: Study closed following exhaustion of available project funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stig Holm Ovesen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390708
- Sponsor's protocol ID
- AID-STROKE
- Acronym
- AID-STROKE
- Status last verified
- Aug 2026
- First submitted
- 29 Jan 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets will not be shared due to legal and privacy restrictions associated with data approved for use in a quality improvement study.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Artificial Intelligence-Assisted Magnetic Resonance Imaging Diagnostic Strategy in a Tertiary Stroke Center-a Diagnostic Accuracy Study
- ClinicalTrials.gov ID
- NCT07390708
- Acronym / sponsor ID
- AID-STROKE / AID-STROKE
- Conditions
- Stroke, Stroke Assessment
- Keywords
- stroke, MRI, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study closed following exhaustion of available project funding.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Quality improvement study with prospective observational design. The study monitors the diagnostic accuracy of an AI-assisted resident radiologist-termed the AI-ResRad diagnostic strategy-compared to an on-call specialist neuroradiologist-termed the SpecNeuroRad strategy-in interpreting stroke MRIs in patients with known onset.
The study includes a pre-planned sub-study evaluating the diagnostic accuracy of neurologists and AI-assisted neurologists.
Detailed description
Current clinical practice and the supporting evidence base rely on interpretations by specialist neuroradiologists. Modern radiology departments face increasing imaging demands while contending with limited resources-including a shortage of specialist neuroradiologists. In the ideal setting, patients are evaluated in real time by a vascular neurologist and a neuroradiologist, who synchronously integrate clinical and imaging findings. In such cases, thrombolysis decisions can be re-evaluated concurrently with MRI acquisition, initiating treatment within minutes of scan completion. Although modern stroke MRI protocols can be completed in as little as 10 minutes, these rapid-response team activations often consume a disproportionate share of specialist time and availability. Consequently, real-world clinical practice frequently involves alternative team configurations, including resident radiologists, resident neurologists, and remote specialist consultations-compositions that vary depending on the on-call team's experience, time of day, and day of the week.
Artificial intelligence (AI) can support the team with image interpretation, potentially optimizing time and resources. Recent studies have explored the role of AI-assisted stroke workflows and its ability to accurately detect ischemic lesions and hemorrhagic stroke-demonstrating promising encouraging diagnostic performance. However, there remains a need for prospective studies evaluating the real-world diagnostic accuracy of AI assistance as applied within its intended clinical use context To further understand the potential contributions of AI-assistance and resident radiologist interpretations, we designed the AID-STROKE accuracy study, under the Danish Quality Improvement legal and design framework.
Sub-study: An Artificial Intelligence-Assisted Neurologist-based Diagnostic Strategy in Magnetic Resonance Imaging of Acute Stroke Patients with Known Onset-a Diagnostic Accuracy Study
This pre-specified sub-study will be conducted in patients received at one of the hospitals (Gødstrup Regional Hospital)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute stroke with known onset | – | Diagnostic Test: Index test (AI-ResRad), Diagnostic Test: Reference test (SpecNeuroRad), Diagnostic Test: Comparative Index tests: ResRad and AI-SpecNeuroRad, Diagnostic Test: Neurologist Diagnostic Accuracy (Sub-study outcome)Adult patients suspected of stroke with known onset who meet the rapid response stroke activation and MRI criteria at Aarhus University Hospital and Gødstrup Regional Hospital will be included consecutively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients suspected of stroke with known onset who meet the rapid response stroke activation and MRI criteria at Aarhus University Hospital and Gødstrup Regional Hospital will be included consecutively.
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Stroke team activation
- Thrombolysis candidate
- Known symptom onset
- MRI candidate
Key exclusion criteria (4 listed)
- Prior inclusion
- Previous MRI in the same course of hospitalization
- No resident radiologist on call
- Participation in the neurologists' sub-study is limited to participants enrolled at one of the two participating sites at Gødstrup Regional Hospital.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Index test (AI-ResRad)Eligible residents will review MRI sequences from the local PACS as they become available. During this process, they will maintain real-time communication-in person or via phone-with the treating neurologist, who will provide relevant clinical information. Simultaneously, the resident will have access to the AI output. Residents will have full access to the patient's electronic medical record and prior imaging. After integrating these inputs, the resident will complete an AI-assisted MRI interpretation using a predefined survey structure. | Diagnostic test | Acute stroke with known onset |
| Reference test (SpecNeuroRad)Before any MRI sequences have been finalized, the resident will notify the on-call specialist neuroradiologist and pass on the clinical information received from the neurologist. The neuroradiologist will then independently review the MRI sequences as they become available in PACS, without access to the resident's interpretation or the AI results. They will also access the patient's electronic medical record and prior imaging. Once both parties have completed their respective surveys, the resident will call the neuroradiologist to jointly deliver an oral MRI interpretation to the neurologist. The radiologic information system's written radiology report may be completed by the neuroradiologist or the resident, with final sign-off by the neuroradiologist. | Diagnostic test | Acute stroke with known onset |
| Comparative Index tests: ResRad and AI-SpecNeuroRadTwo additional comparative test strategies will be evaluated: * ResRad: Prior to accessing AI results, residents will complete a non-assisted MRI interpretation. * AI-SpecNeuroRad: After completing their initial non-assisted interpretation (SpecNeuroRad), the specialist neuroradiologist will be granted access to the AI output. They will then submit a second interpretation (AI-assisted) using the same survey platform. To enforce internal blinding between non-assisted and AI-assisted interpretations, AI outputs are only revealed upon manual activation, which is timestamped by the system. Interpretation surveys are also timestamped at submission. All non-assisted interpretations must be submitted prior to AI output activation to be considered valid. Cases that violate this timestamp sequence will be excluded from final analyses to ensure methodological integrity. | Diagnostic test | Acute stroke with known onset |
| Neurologist Diagnostic Accuracy (Sub-study outcome)Simultaneously with the radiologists' MRI interpretations with and without AI assistance according to the study workflow, the neurologist responsible for patient management will complete a similar MRI interpretation survey. The neurologist will first interpret the MRI without AI assistance and subsequently with AI assistance, mirroring the radiologist study workflow. The neurologist will be blinded to the radiologists' interpretations while completing their assessments, and likewise, the radiologists will be blinded to the neurologist's interpretations. | Diagnostic test | Acute stroke with known onset |
Primary outcome
Composite agreement
Time frame: Immediately after the procedure
Overall agreement is defined as the proportion of patients for whom the AI-ResRad and SpecNeuroRad agree on all MRI pattern items included in the MRI interpretation survey: (1) DWI lesion and (2) hemorrhage.
3 secondary outcomes
Diagnostic Accuracy
Time frame: immediately after the procedure
Comparative Diagnostic Accuracy
Time frame: immediately after the procedure
Concordance SpecNeuroRad
Time frame: immediately after the procedure
Results and safety
The study was stopped early (reason given: Study closed following exhaustion of available project funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No. The datasets will not be shared due to legal and privacy restrictions associated with data approved for use in a quality improvement study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Stroke Assessment, run by Aarhus University Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study closed following exhaustion of available project funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite agreement (time frame: Immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026; AzTrials last refreshed its copy on 4 Nov 2026.