This study (IEDAL study) intends to prospectively enroll more than 6450 patients who will undergo head CT angiography (CTA) scanning in the outpatient clinic. It will be carried out in 21 hospitals in more than 10 provinces in China. The patient's head CTA images will be randomly assigned to the True-AI and Sham-AI group with a ratio of 1:1, and the patients and radiologists are unaware of the allocation. The primary outcomes are sensitivity and specificity of detecting intracranial aneurysms. The secondary outcomes focus on the prognosis and outcomes of the patients.
Adult inpatients and outpatients who are scheduled for head CTA scanning.
Age under 18 years.
Patients with contraindications to CTA.
Modified Rankin Scale (mRS) score > 3.
Refuse to sign informed consent.
Parallel
True-AI-integrated intracranial aneurysms diagnosis strategy
DeviceThe True-AI deep-learning based model for intracranial aneurysms detection had a patient-wise sensitivity, lesion-wise sensitivity and specificity of 0.96, 0.87, and 0.80 in the internal validation dataset.
Sham-AI-integrated intracranial aneurysms diagnosis strategy
DeviceThe Sham-AI deep-learning based model for intracranial aneurysms detection is designed to have a sensitivity close to 0% and a similar specificity to the True-AI. In the internal validation dataset, the Sham-AI had a patient-wise sensitivity, lesion-wise sensitivity, specificity of 0.02, 0.01, and 0.80, respectively.
To compare diagnostic sensitivity of intracrnial aneurysms between intervention and control arm.
The proportion of examinations in which at least one aneurysm is discovered and indicated among groundtruth aneurysms.
To compare diagnostic specificity of intracrnial aneurysms between intervention and control arm.
The proportion of examinations in which no aneurysms are spotted by the reader among groundtruth non-aneurysms.
To compare other diagnostic performances for intracranial aneurysms between intervention and control arm.
To compare accuracy, lesion-wise sensitivity, positive predictive value and negative predictive value for intracranial aneurysms between intervention and control arm.
To compare diagnostic performances for other intracranial lesions between intervention and control arm.
The sensitivity, specificity, accuracy, positive predictive value and negative predictive value for intracranial arterial stenosis, occlusion, and intracranial tumors are compared between intervention and control arm.
To compare detection rates of intracranial lesions according to Radiology Reports between intervention and control arm.
Detection rates of intracranial aneurysms, intracranial arterial stenosis, occlusion, and intracranial tumors according to Radiology Reports are compared between intervention and control arm.
To assess the workload of head CT angiography interpretation.
Time of interpreting head CT angiography images, number of consensus meeting are compared between intervention and control arm.
Patient-wise sensitivity and specificity at different centers, provinces, geography areas and levels of physician.
To compare diagnostic performances of patient-wise sensitivity and specificity for intracranial aneurysms between intervention and control arm in subgroups of different centers, provinces, geography areas and physician level.
Subgroup analysis of different size (< 5 mm vs. ≥ 5 mm), locations of intracranial aneurysms.
To compare diagnostic performances for intracranial aneurysms between intervention and control arm in subgroups of different size (internal carotid artery vs. middle cerebral artery vs. anterior cerebral artery vs. posterior communication artery vs. anterior communication artery vs. vertebral basilar artery vs. others), locations (internal carotid artery vs. middle cerebral artery vs. anterior cerebral artery vs. posterior communication artery vs. anterior communication artery vs. vertebral basilar artery vs. others) of intracranial aneurysms.
Subgroup analysis of different gender (male vs. female), age (≤ 54 years or. >54 years), subarachnoid hemorrhage status (with vs. without SAH) of patients
To compare diagnostic performances for intracranial aneurysms between intervention and control arm in subgroups of different gender (male vs. female), age (≤ 54 years or. \>54 years), subarachnoid hemorrhage status (with vs. without SAH) of patients.
Patient-wise sensitivity and specificity for patients with previous head digital subtraction angiography or surgery or not.
To compare diagnostic performances of patient-wise sensitivity and specificity for intracranial aneurysms between intervention and control arm in subgroups of patients with previous head angiography or surgery or not.
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