An Artificial Intelligence-Assisted Magnetic Resonance Imaging Diagnostic Strategy in a Tertiary Stroke Center-a Diagnostic Accuracy Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Composite agreement
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Stroke team activation
- •Thrombolysis candidate
- •Known symptom onset
- •MRI candidate
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Reference test (SpecNeuroRad) (Diagnostic Test)
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.
干预措施: Comparative Index tests: ResRad and AI-SpecNeuroRad (Diagnostic Test)
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.
干预措施: Neurologist Diagnostic Accuracy (Sub-study outcome) (Diagnostic Test)
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.
干预措施: Index test (AI-ResRad) (Diagnostic Test)
结局指标
主要结局
Composite agreement
时间窗: 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.
次要结局
- Diagnostic Accuracy(immediately after the procedure)
- Comparative Diagnostic Accuracy(immediately after the procedure)
- Concordance SpecNeuroRad(immediately after the procedure)
研究者
Stig Holm Ovesen
Principal Investigator
Aarhus University Hospital