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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6,450
- 试验地点
- 40
- 主要终点
- To compare diagnostic specificity of intracrnial aneurysms between intervention and control arm.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Study participants, nurses acquiring for patients' consent and radiographers acquiring head computered tomograhy angiography exams will be blinded to the randomization as it is automatically performed after the exam has been acquired.
A Sham-AI for the automatic detection of intracranial aneurysms has been delicately designed to mimic the True-AI model with a sensitivity close to zero and a similar specificity to True-AI. Thereforem, the participating radiologists interpreting head computered tomograhy angiography exams will also be blinded to the allocation of the AI models.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult inpatients and outpatients who are scheduled for head CTA scanning.
排除标准
- •Age under 18 years.
- •Patients with contraindications to CTA.
- •Modified Rankin Scale (mRS) score >
- •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.
结局指标
主要结局
To compare diagnostic specificity of intracrnial aneurysms between intervention and control arm.
时间窗: 6 months.
The proportion of examinations in which no aneurysms are spotted by the reader among groundtruth non-aneurysms.
To compare diagnostic sensitivity of intracrnial aneurysms between intervention and control arm.
时间窗: 6 months.
The proportion of examinations in which at least one aneurysm is discovered and indicated among groundtruth aneurysms.
次要结局
- Rate of aneurysm rupture during patient follow-up.(At 12-month follow-up.)
- To assess resource use.(At 3-month and 12-month follow-up.)
- Rate of patients of subsequent hospitalization during patient follow-up.(At 3-month and 12-month follow-up.)
- Rate of hospitalization for intracranial aneurysms during patient follow-up.(At 3-month and 12-month follow-up.)
- Detection rate of intracranial aneurysms among digital subtraction angiographys (DSA) during patient follow-up.(At 3-month and 12-month follow-up.)
- Detection rate of no abnormality among digital subtraction angiographys (DSA) during patient follow-up.(At 3-month and 12-month follow-up.)
- Morphological change by head CTA or magnetic resonance angiography at the 12-month follow-up.(At 12-month follow-up.)
- To compare other diagnostic performances for intracranial aneurysms between intervention and control arm.(6 months.)
- To compare detection rates of intracranial lesions according to Radiology Reports between intervention and control arm.(6 months.)
- To assess the workload of head CT angiography interpretation.(6 months.)
- In-hospital mortality rate during patient follow-up.(At 3-month and 12-month follow-up.)
- Length of hospital stay during patient follow-up.(At 3-month and 12-month follow-up.)
- To compare diagnostic performances for other intracranial lesions between intervention and control arm.(6 months.)
- Rate of patients undergoing digital subtraction angiography (DSA) during patient follow-up.(At 3-month and 12-month follow-up.)
- Distribution of the methods for aneurysms management (conservative/coil/clip/others) during patient follow-up.(At 3-month and 12-month follow-up.)
- Rate of recurrence or residual of intracranial aneurysm after surgery during patient follow-up.(At 12-month follow-up.)
- Rates of aneurysm treatment related complications during patient follow-up.(At 3-month and 12-month follow-up.)
- Life quality assessed by EuroQol 5-Dimensional, 5-Level (EQ-5D-5L) during patient follow-up.(At 3-month and 12-month follow-up.)
- Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI) during patient follow-up.(At 3-month and 12-month follow-up.)
- All-cause mortality during patient follow-up.(At 3-month and 12-month follow-up.)
- Morbidity (modified Rankin Score ≥ 3) from intracranial haemorrhage or treatment during patient follow-up.(At 3-month and 12-month follow-up.)
- Anxiety and depression assessed by Hospital Anxiety and Depression Scale (HADS) scores during patient follow-up.(At 3-month and 12-month follow-up.)
- General health assessed by Short-Form 36 Health Survey (SF-36) scores during patient follow-up.(At 3-month and 12-month follow-up.)
- Functional outcome assessed by Modified Rankin Scale (mRS) scores during patient follow-up.(At 3-month and 12-month follow-up.)
- Rate of aneurysm growth during patient follow-up.(At 12-month follow-up.)
- Rate of subarachnoid hemorrhage (SAH) during patient follow-up.(At 3-month and 12-month follow-up.)
- Rate of other types of stroke (hemorrhagic stroke, ischemic stroke) during patient follow-up.(At 3-month and 12-month follow-up.)
- Mortality of aneurysms-rupture during patient follow-up.(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.(At 3-month and 12-month follow-up.)
- Depression Screening assessed by Patient Health Questionnaire-9 (PHQ-9) scores during patient follow-up.(At 3-month and 12-month follow-up.)
研究者
Zhang longjiang,MD
Head of Radiology
Jinling Hospital, China