NCT Number: NCT06118840
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.
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All sexes
Interventional
Not applicable
The First Affiliated Hospital of University of Science and Technology of China, Hefei, Anhui, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 6 months.
The proportion of examinations in which at least one aneurysm is discovered and indicated among groundtruth aneurysms.
Time frame: 6 months.
The proportion of examinations in which no aneurysms are spotted by the reader among groundtruth non-aneurysms.
Time frame: 6 months.
To compare accuracy, lesion-wise sensitivity, positive predictive value and negative predictive value for intracranial aneurysms between intervention and control arm.
Time frame: 6 months.
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.
Time frame: 6 months.
Detection rates of intracranial aneurysms, intracranial arterial stenosis, occlusion, and intracranial tumors according to Radiology Reports are compared between intervention and control arm.
Time frame: 6 months.
Time of interpreting head CT angiography images, number of consensus meeting are compared between intervention and control arm.
Time frame: At 3-month and 12-month follow-up.
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.
Time frame: At 3-month and 12-month follow-up.
Rate of patients of subsequent hospitalization is compared between intervention and control arm.
Time frame: At 3-month and 12-month follow-up.
In-hospital mortality rate is compared between intervention and control arm.
Time frame: At 3-month and 12-month follow-up.
Morbidity (modified Rankin Score ≥ 3) from intracranial haemorrhage or treatment is compared between intervention and control arm.
Time frame: At 3-month and 12-month follow-up.
Length of hospital stay is compared between intervention and control arm.
Time frame: At 3-month and 12-month follow-up.
Rate of hospitalization for intracranial aneurysms is compared between intervention and control arm.
Time frame: At 3-month and 12-month follow-up.
Rate of patients undergoing digital subtraction angiography (DSA) is compared between intervention and control arm.
Time frame: At 3-month and 12-month follow-up.
Detection rate of intracranial aneurysms among digital subtraction angiographys (DSA) is compared between intervention and control arm.
Time frame: At 3-month and 12-month follow-up.
Detection rate of no abnormality among digital subtraction angiographys (DSA) is compared between intervention and control arm.
Time frame: At 3-month and 12-month follow-up.
Distribution of the methods for aneurysms management (conservative/coil/clip/others) is compared between intervention and control arm.
Time frame: At 3-month and 12-month follow-up.
Rate of aneurysm treatment related complications (intraoperative rupture, stroke, et al) is compared between intervention and control arm.
Time frame: At 12-month follow-up.
Rate of recurrence or residual of intracranial aneurysm after surgery is compared between intervention and control arm.
Time frame: At 3-month and 12-month 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.
Time frame: At 3-month and 12-month 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.
Time frame: At 3-month and 12-month 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.
Time frame: At 3-month and 12-month 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.
Time frame: At 3-month and 12-month 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.
Time frame: At 3-month and 12-month follow-up.
General health assessed by Short-Form 36 Health Survey (SF-36) scores are compared between intervention and control arm.
Time frame: At 3-month and 12-month 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.
Time frame: At 3-month and 12-month follow-up.
All-cause mortality is compared between intervention and control arm.
Time frame: At 12-month follow-up.
Rate of aneurysm growth is compared between intervention and control arm.
Time frame: At 12-month follow-up.
Rate of aneurysm rupture is compared between intervention and control arm.
Time frame: At 3-month and 12-month follow-up.
Rate of subarachnoid hemorrhage (SAH) is compared between intervention and control arm.
Time frame: At 3-month and 12-month follow-up.
Rate of other types of stroke (hemorrhagic stroke, ischemic stroke) is compared between intervention and control arm.
Time frame: At 3-month and 12-month follow-up.
Mortality of aneurysms-rupture is compared between intervention and control arm.
Time frame: At 12-month follow-up.
Morphological change by head CTA or magnetic resonance angiography is assessed.
Time frame: 6 months.
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.
Time frame: 6 months.
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.
Time frame: 6 months.
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.
Time frame: 6 months.
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.
Time frame: 6 months.
To compare diagnostic performances of patient-wise sensitivity and specificity for intracranial aneurysms between intervention and control arm in subgroups of patients with subsequent head angiography or surgery or not.
Time frame: 6 months.
The monthly reported detection rates of intracranial aneurysms, tumors, stenosis, and occlusive are calculated and compared with the reported detection rates in the previous 3 months during the trial.
Time frame: 6 months.
Dynamic changes in sensitivity and specificity of aneurysm diagnosis from the first 7-days through to the last 7-days of all center trials.
Contact information is provided by the study sponsor or research team.
Jinling Hospital, China
Other
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
Acronym: IDEAL
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