IDEAL Study: Blinded RCT for the Impact of AI Model for Cerebral Aneurysms Detection on Patients' Diagnosis and Outcomes

Study Overview
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Brief Summary
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This study (IEDAL study) intends to prospectively enroll more than 6800 patients who will undergo head CT angiography (CTA) scanning in the outpatient clinic. It will be carried out in 25 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.

Detailed Description
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A multicenter, prospective, double-blind, randomized controlled trial will be conducted (IDEAL study). Patients who are scheduled to undergo cranial CT angiography (CTA) scanning will be randomly divided into two groups with a ratio of 1:1, one of the group will be assigned to True-AI aided intracranial aneurysms diagnosis strategy (True-AI group) and the other will be assigned to Sham-AI aided intracranial aneurysms diagnosis strategy (Sham-AI group, which has a sensitivity close to 0% and a similar specificity to True-AI). The primary outcomes are diagnostic sensitivity and specificity of detecting aneurysms. Secondary endpoints include other diagnostic performance indexes for intracranial aneurysms; diagnostic performances for other intracranial lesions for intracranial arterial stenosis, occlusion, and intracranial tumors; detection rates of intracranial lesions according to Radiology Reports; workload of head CTA interpretation; resource use; treatment-related indexes during patient follow-up (e.g. clinical follow-up, hospitalization, rate of patients undergoing DSA); life quality; outcomes of aneurysm-related events; repeat head CTA or MRA at 12-month follow; cost-effectiveness analysis between intervention and control arm to evaluate the short- and longterm influence of AI system to the routine practice and patients' prognosis and outcomes.

Official Title
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Assessing the Impact of an Artificial Intelligence-Based Model for Intracranial Aneurysm Detection in CT Angiography on Patients' Diagnosis and Outcomes: The IDEAL Study - A Web-Based Multicenter, Double-Blinded Randomized Controlled Trial

Conditions
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Intracranial Aneurysm, CT Angiography, Deep Learning, Double Bind Interaction

Intervention / Treatment
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* Device: True-AI-integrated intracranial aneurysms diagnosis strategy
* Device: Sham-AI-integrated intracranial aneurysms diagnosis strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in the outpatient setting who are scheduled to undergo head CTA scanning in 25 hospitals in more than 10 provinces in China. Exclusion Criteria: Age under 18 years. Patients with contraindications to CTA. Modified Rankin Scale (mRS) score > 3. Refuse to sign informed consent. Participation in other clinical studies of intracranial aneurysms. Patients with failed head CTA scanning or incomplete image data, or poor image quality.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: True-AI-integrated intracranial aneurysms diagnosis strategy<br>For patients who underwent head CTA and assigned to True-AI group, they will be diagnosed by a radiologist who are aided by the True-AI-integrated intracranial aneurysms diagnosis strategy. | Device: True-AI-integrated intracranial aneurysms diagnosis strategy<br>* The 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.<br>|
| Sham Comparator: Sham-AI-integrated intracranial aneurysms diagnosis strategy<br>For patients who underwent head CTA and assigned to Sham-AI group, they will be diagnosed by a radiologist who are aided by the Sham-AI-integrated intracranial aneurysms diagnosis strategy. To mimic the True-AI, the Sham-AI had a sensitivity close to 0% and a similar specificity to the True-AI. | Device: Sham-AI-integrated intracranial aneurysms diagnosis strategy<br>* The 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months. | 
| 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. | 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months. | 
| 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. | 6 months. | 
| 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. | 6 months. | 
| 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. | 6 months. | 
| To assess resource use. | The number of care encounters (in-person) during follow-up, total number of outpatient encounters for aneurysm referral, total number of cerebral artery disease testing are compared between intervention and control arm. | At 3-month and 12-month follow-up. | 
| Rate of patients of subsequent hospitalization during patient follow-up. | Rate of patients of subsequent hospitalization is compared between intervention and control arm. | At 3-month and 12-month follow-up. | 
| In-hospital mortality rate during patient follow-up. | In-hospital mortality rate is compared between intervention and control arm. | At 3-month and 12-month follow-up. | 
| Morbidity (modified Rankin Score ≥ 3) from intracranial haemorrhage or treatment during patient follow-up. | Morbidity (modified Rankin Score ≥ 3) from intracranial haemorrhage or treatment is compared between intervention and control arm. | At 3-month and 12-month follow-up. | 
| Length of hospital stay during patient follow-up. | Length of hospital stay is compared between intervention and control arm. | At 3-month and 12-month follow-up. | 
| Rate of hospitalization for intracranial aneurysms during patient follow-up. | Rate of hospitalization for intracranial aneurysms is compared between intervention and control arm. | At 3-month and 12-month follow-up. | 
| Rate of patients undergoing digital subtraction angiography (DSA) during patient follow-up. | Rate of patients undergoing digital subtraction angiography (DSA) is compared between intervention and control arm. | At 3-month and 12-month follow-up. | 
| Detection rate of intracranial aneurysms among digital subtraction angiographys (DSA) during patient follow-up. | Detection rate of intracranial aneurysms among digital subtraction angiographys (DSA) is compared between intervention and control arm. | At 3-month and 12-month follow-up. | 
| Detection rate of no abnormality among digital subtraction angiographys (DSA) during patient follow-up. | Detection rate of no abnormality among digital subtraction angiographys (DSA) is compared between intervention and control arm. | At 3-month and 12-month follow-up. | 
| Distribution of the methods for aneurysms management (conservative/coil/clip/others) during patient follow-up. | Distribution of the methods for aneurysms management (conservative/coil/clip/others) is compared between intervention and control arm. | At 3-month and 12-month follow-up. | 
| Rates of aneurysm treatment related complications during patient follow-up. | Rate of aneurysm treatment related complications (intraoperative rupture, stroke, et al) is compared between intervention and control arm. | At 3-month and 12-month follow-up. | 
| Rate of recurrence or residual of intracranial aneurysm after surgery during patient follow-up. | Rate of recurrence or residual of intracranial aneurysm after surgery is compared between intervention and control arm. | At 12-month follow-up. | 
| Life quality assessed by EuroQol 5-Dimensional, 5-Level (EQ-5D-5L) during patient follow-up. | Life quality assessed by EuroQol 5-Dimensional, 5-Level (EQ-5D-5L) scores are compared between intervention and control arm, which ranges from 5 to 25, and higher scores mean a worse outcome. | At 3-month and 12-month follow-up. | 
| Restrictions in daily activities assessed by Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P) scores during patient follow-up. | Restrictions in daily activities assessed by Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P) scores are compared between intervention and control arm. | At 3-month and 12-month follow-up. | 
| Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI) during patient follow-up. | Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI) is compared between intervention and control arm, which ranges from 0 to 21, and higher scores mean a worse outcome. | At 3-month and 12-month follow-up. | 
| Depression Screening assessed by Patient Health Questionnaire-9 (PHQ-9) scores during patient follow-up. | Depression Screening assessed by Patient Health Questionnaire-9 (PHQ-9) scores are compared between intervention and control arm, which ranges from 0 to 27, and higher scores mean a worse outcome. | At 3-month and 12-month follow-up. | 
| Anxiety and depression assessed by Hospital Anxiety and Depression Scale (HADS) scores during patient follow-up. | Anxiety and depression assessed by Hospital Anxiety and Depression Scale (HADS) scores are compared between intervention and control arm, which ranges from 0 to 21, and higher scores mean a worse outcome. | At 3-month and 12-month follow-up. | 
| General health assessed by Short-Form 36 Health Survey (SF-36) scores during patient follow-up. | General health assessed by Short-Form 36 Health Survey (SF-36) scores are compared between intervention and control arm. | At 3-month and 12-month follow-up. | 
| Functional outcome assessed by Modified Rankin Scale (mRS) scores during patient follow-up. | Functional outcome assessed by Modified Rankin Scale (mRS) scores are compared between intervention and control arm, which ranges from 0 to 5, and higher scores mean a worse outcome. | At 3-month and 12-month follow-up. | 
| All-cause mortality during patient follow-up. | All-cause mortality is compared between intervention and control arm. | At 3-month and 12-month follow-up. | 
| Rate of aneurysm growth during patient follow-up. | Rate of aneurysm growth is compared between intervention and control arm. | At 12-month follow-up. | 
| Rate of aneurysm rupture during patient follow-up. | Rate of aneurysm rupture is compared between intervention and control arm. | At 12-month follow-up. | 
| Rate of subarachnoid hemorrhage (SAH) during patient follow-up. | Rate of subarachnoid hemorrhage (SAH) is compared between intervention and control arm. | At 3-month and 12-month follow-up. | 
| Rate of other types of stroke (hemorrhagic stroke, ischemic stroke) during patient follow-up. | Rate of other types of stroke (hemorrhagic stroke, ischemic stroke) is compared between intervention and control arm. | At 3-month and 12-month follow-up. | 
| Mortality of aneurysms-rupture during patient follow-up. | Mortality of aneurysms-rupture is compared between intervention and control arm. | At 3-month and 12-month follow-up. | 
| Morphological change by head CTA or magnetic resonance angiography at the 12-month follow-up. | Morphological change by head CTA or magnetic resonance angiography is assessed. | At 12-month follow-up. |