Artificial Intelligence-Assisted Magnetic Resonance Imaging Diagnostic Strategy in a Tertiary Stroke Center

NCT07390708 | Not Yet Recruiting

• 1 other identifier: AID-STROKE
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

Brief 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 known onset. The study includes a pre-planned sub-study evaluating the diagnostic accuracy of neurologists and AI-assisted neurologists.

Conditions

Stroke Assessment; Stroke

Keywords

stroke; MRI; Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately after the procedure

Secondary Outcomes (3)

• Diagnostic Accuracy

  immediately after the procedure

• Comparative Diagnostic Accuracy

  immediately after the procedure

• Concordance SpecNeuroRad

  immediately after the procedure

Other Outcomes (2)

• Neurologists' Diagnostic Accuracy (Sub-study)

  Immediately after the procedure

• Neurologists' Composite Agreement (Sub-study)

  Immediately after the procedure

Study Arms (1)

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.

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)

Interventions

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.

Acute stroke with known onset

Comparative Index tests: ResRad and AI-SpecNeuroRad DIAGNOSTIC_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.

Acute stroke with known onset

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.

Acute stroke with known onset

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.

Acute stroke with known onset

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Age ≥ 18 years
• Stroke team activation
• Thrombolysis candidate
• Known symptom onset
• MRI candidate

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (2)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Gødstrup Regional Hospital

Gødstrup, Denmark

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)