Clinical trial NCT06118840: IDEAL Study: Blinded RCT for the Impact of AI Model for Cerebral Aneurysms Detection on Patients' Diagnosis and Outcomes
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intracranial Aneurysm
CT Angiography
Deep Learning
Double Bind Interaction
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 6800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: To compare diagnostic sensitivity of intracrnial aneurysms between intervention and control arm.
timeFrame: 6 months.
measure: To compare diagnostic specificity of intracrnial aneurysms between intervention and control arm.
timeFrame: 6 months.
Secondary outcomes:
measure: To compare other diagnostic performances for intracranial aneurysms between intervention and control arm.
timeFrame: 6 months.
measure: To compare diagnostic performances for other intracranial lesions between intervention and control arm.
timeFrame: 6 months.
measure: To compare detection rates of intracranial lesions according to Radiology Reports between intervention and control arm.
timeFrame: 6 months.
measure: To assess the workload of head CT angiography interpretation.
timeFrame: 6 months.
measure: To assess resource use.
timeFrame: At 3-month and 12-month follow-up.
measure: Rate of patients of subsequent hospitalization during patient follow-up.
timeFrame: At 3-month and 12-month follow-up.
measure: In-hospital mortality rate during patient follow-up.
timeFrame: At 3-month and 12-month follow-up.
measure: Morbidity (modified Rankin Score ≥ 3) from intracranial haemorrhage or treatment during patient follow-up.
timeFrame: At 3-month and 12-month follow-up.
measure: Length of hospital stay during patient follow-up.
timeFrame: At 3-month and 12-month follow-up.
measure: Rate of hospitalization for intracranial aneurysms during patient follow-up.
timeFrame: At 3-month and 12-month follow-up.
measure: Rate of patients undergoing digital subtraction angiography (DSA) during patient follow-up.
timeFrame: At 3-month and 12-month follow-up.
measure: Detection rate of intracranial aneurysms among digital subtraction angiographys (DSA) during patient follow-up.
timeFrame: At 3-month and 12-month follow-up.
measure: Detection rate of no abnormality among digital subtraction angiographys (DSA) during patient follow-up.
timeFrame: At 3-month and 12-month follow-up.
measure: Distribution of the methods for aneurysms management (conservative/coil/clip/others) during patient follow-up.
timeFrame: At 3-month and 12-month follow-up.
measure: Rates of aneurysm treatment related complications during patient follow-up.
timeFrame: At 3-month and 12-month follow-up.
measure: Rate of recurrence or residual of intracranial aneurysm after surgery during patient follow-up.
timeFrame: At 12-month follow-up.
measure: Life quality assessed by EuroQol 5-Dimensional, 5-Level (EQ-5D-5L) during patient follow-up.
timeFrame: At 3-month and 12-month follow-up.
measure: Restrictions in daily activities assessed by Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P) scores during patient follow-up.
timeFrame: At 3-month and 12-month follow-up.
measure: Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI) during patient follow-up.
timeFrame: At 3-month and 12-month follow-up.
measure: Depression Screening assessed by Patient Health Questionnaire-9 (PHQ-9) scores during patient follow-up.
timeFrame: At 3-month and 12-month follow-up.
measure: Anxiety and depression assessed by Hospital Anxiety and Depression Scale (HADS) scores during patient follow-up.
timeFrame: At 3-month and 12-month follow-up.
measure: General health assessed by Short-Form 36 Health Survey (SF-36) scores during patient follow-up.
timeFrame: At 3-month and 12-month follow-up.
measure: Functional outcome assessed by Modified Rankin Scale (mRS) scores during patient follow-up.
timeFrame: At 3-month and 12-month follow-up.
measure: All-cause mortality during patient follow-up.
timeFrame: At 3-month and 12-month follow-up.
measure: Rate of aneurysm growth during patient follow-up.
timeFrame: At 12-month follow-up.
measure: Rate of aneurysm rupture during patient follow-up.
timeFrame: At 12-month follow-up.
measure: Rate of subarachnoid hemorrhage (SAH) during patient follow-up.
timeFrame: At 3-month and 12-month follow-up.
measure: Rate of other types of stroke (hemorrhagic stroke, ischemic stroke) during patient follow-up.
timeFrame: At 3-month and 12-month follow-up.
measure: Mortality of aneurysms-rupture during patient follow-up.
timeFrame: At 3-month and 12-month follow-up.
measure: Morphological change by head CTA or magnetic resonance angiography at the 12-month follow-up.
timeFrame: At 12-month follow-up.
Other outcomes:
measure: Patient-wise sensitivity and specificity at different centers, provinces, geography areas and levels of physician.
timeFrame: 6 months.
measure: Subgroup analysis of different size (< 5 mm vs. ≥ 5 mm), locations of intracranial aneurysms.
timeFrame: 6 months.
measure: Subgroup analysis of different gender (male vs. female), age (≤ 54 years or. >54 years), subarachnoid hemorrhage status (with vs. without SAH) of patients
timeFrame: 6 months.
measure: Patient-wise sensitivity and specificity for patients with previous head digital subtraction angiography or surgery or not.
timeFrame: 6 months.
measure: Patient-wise sensitivity and specificity for patients with subsequent head digital subtraction angiography or surgery or not.
timeFrame: 6 months.
measure: Ethical safety outcomes.
timeFrame: 6 months.
measure: Learning curve of AI-augmented intracranial aneurysm diagnosis.
timeFrame: 6 months.
Locations:
city: Nanjing
country: China
facility: Research Institute Of Medical Imaging Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References: