IDEAL Study: Blinded RCT for the Impact of AI Model for Cerebral Aneurysms Detection on Patients' Diagnosis and Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: True-AI-integrated intracranial aneurysms diagnosis strategy, Sham-AI-integrated intracranial aneurysms diagnosis strategy.
- Who it may be relevant to
- Registry conditions: Intracranial Aneurysm, CT Angiography, Deep Learning, Double Bind Interaction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Device True-AI-integrated intracranial aneurysms diagnosis strategy
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. - Device Sham-AI-integrated intracranial aneurysms diagnosis strategy
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.
Primary outcome measures
- To compare diagnostic sensitivity of intracrnial aneurysms between intervention and control arm. [Time frame: 6 months.]
- To compare diagnostic specificity of intracrnial aneurysms between intervention and control arm. [Time frame: 6 months.]
Secondary outcome measures (12)
- To compare other diagnostic performances for intracranial aneurysms between intervention and control arm. [Time frame: 6 months.]
- To compare diagnostic performances for other intracranial lesions between intervention and control arm. [Time frame: 6 months.]
- To compare detection rates of intracranial lesions according to Radiology Reports between intervention and control arm. [Time frame: 6 months.]
- To assess the workload of head CT angiography interpretation. [Time frame: 6 months.]
- To assess resource use. [Time frame: At 3-month and 12-month follow-up.]
- Rate of patients of subsequent hospitalization during patient follow-up. [Time frame: At 3-month and 12-month follow-up.]
- In-hospital mortality rate during patient follow-up. [Time frame: At 3-month and 12-month follow-up.]
- Morbidity (modified Rankin Score ≥ 3) from intracranial haemorrhage or treatment during patient follow-up. [Time frame: At 3-month and 12-month follow-up.]
- Length of hospital stay during patient follow-up. [Time frame: At 3-month and 12-month follow-up.]
- Rate of hospitalization for intracranial aneurysms during patient follow-up. [Time frame: At 3-month and 12-month follow-up.]
- Rate of patients undergoing digital subtraction angiography (DSA) during patient follow-up. [Time frame: At 3-month and 12-month follow-up.]
- Detection rate of intracranial aneurysms among digital subtraction angiographys (DSA) during patient follow-up. [Time frame: At 3-month and 12-month follow-up.]
Eligibility criteria
Inclusion criteria
- Adult inpatients and outpatients who are scheduled for head CTA scanning.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Diagnostic
Study locations
China · 21 centers
- The First Affiliated Hospital of University of Science and Technology of China — Hefei
- The First Affiliated Hospital of Wannan Medical College — Wuhu
- Guizhou Provincial People's Hospital — Guiyang
- First Affiliated Hospital of Zhengzhou University — Zhengzhou
- Shiyan People's Hospital — Shiyan
- Research Institute Of Medical Imaging Jinling Hospital — Nanjing
- Affiliated Hospital of Xuzhou Medical University — Xuzhou
- The First Hospital of Jilin University — Changchun
- … and 13 more centers
Publications
- Shi Z, Hu B, Lu M, Chen Z, Zhang M, Yu Y, Zhou C, Zhong J, Wu B, Zhang X, Wei Y, Zhang LJ; China Aneurysm AI Project Group. Assessing the Impact of an Artificial Intelligence-Based Model for Intracranial Aneurysm Detection in CT Angiography on Patient Diagnosis and Outcomes (IDEAL Study)-a protocol for a multicenter, double-blinded randomized controlled trial. Trials. 2024 Jun 4;25(1):358. doi: 10 PMID 38835091
Identifiers
NCT: NCT06118840 · 2022NZKY-015-05