Intracranial AneurysmIDEALNCT06118840
IDEAL Study: Blinded RCT for the Impact of AI Model for Cerebral Aneurysms Detection on Patients' Diagnosis and Outcomes
A study testing True-AI-integrated intracranial aneurysms diagnosis strategy in people with Intracranial Aneurysm and CT Angiography, run by Jinling Hospital, China at 21 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intracranial Aneurysm, CT Angiography, Deep Learning
- What is being tested?
- True-AI-integrated intracranial aneurysms diagnosis strategy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,450 participants
- Where
- 21 sitesChina
- Study dates
- 20 May 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult inpatients and outpatients who are scheduled for head CTA scanning.
Who cannot join
- 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.
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
China21 sites, 21 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin
Zhang, 86-13843109555, huimao@jlu.edu.cn
- Recruiting
Guizhou Provincial People's Hospital
Guiyang, Guizhou
Wang, 86-18685193598, wangrongpin@126.com
- Recruiting
Hainan General Hospital
Haikou
Chen, 86-13876901502, fenger0802@163.com
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui
Wei, 86-13856005207, weiweill@126.com
- Recruiting
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong
Wang, 86-15168886672, wxming369@163.com
- Recruiting
The First People's Hospital of Kashgar Region
Kashgar
Nijiati, 86-13565662557, mydl0911@163.com
- Recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
He, 86-13888967549, kmmu_hb@163.com
- Recruiting
University Second Hospital
Lanzhou
Zhou, 86-15193107916, zjl601@163.com
- Recruiting
First People's Hospital of Lianyungang
Lianyungang
Gu, 86-13815617997, guyan2020@njmu.edu.cn
- Recruiting
Ma'anshan People's Hospital
Ma’anshan
Yang, 86-13365557527, yanghk1979@163.com
- Recruiting
Research Institute Of Medical Imaging Jinling Hospital
Nanjing, Jiangsu, 210018
longjiang Zhang, MD, 13405833176, kevinzhlj@163.com
- Recruiting
BenQ Medical Center, Affiliated BenQ Hospital of Medical School, Nanjing Medical University
Nanjing
Zhou, 86-13813951215, daniezhou@126.com
- Recruiting
Long Gang Central Hospital of Shenzhen
Shenzhen
Zhang, 86-18026971278, 18819818005@163.com
- Recruiting
Shiyan People's Hospital
Shiyan, Hubei
Li, 86-13597909005, lish1981@126.com
- Recruiting
The Affiliated Suqian First Hospital of Nanjing Medical University
Suqian
Xu, 86-18012186660, keyisq@163.com
- Recruiting
Tianjin Medical University General Hospital
Tianjin
Wang, 86-13820976417, wangjunping_tj@163.com
- Recruiting
Yidu Central Hospital Affiliated to Shandong Second Medical University
Weifang, Shandong
Feng, 86-13562606690, fengqiang220812@163.com
- Recruiting
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui
Zhou, 86-18110876440, zhouyunfeng808@163.com
- Recruiting
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Hu, 86-15262038898, hcfxz@163.com
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan
Wang, 86-13995109434, xdw80@yeah.net
- Recruiting
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Zhang, 86-13673663923, zyg01578@126.com
About this study
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
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.
Read the 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.
- Being tested
- True-AI-integrated intracranial aneurysms diagnosis strategy, Sham-AI-integrated intracranial aneurysms diagnosis strategy
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
True-AI-integrated intracranial aneurysms diagnosis strategyDevice
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.
Sham-AI-integrated intracranial aneurysms diagnosis strategyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| True-AI-integrated intracranial aneurysms diagnosis strategy | Experimental | 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. Receives: Device: True-AI-integrated intracranial aneurysms diagnosis strategy |
| Sham-AI-integrated intracranial aneurysms diagnosis strategy | Sham comparator | 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. Receives: Device: Sham-AI-integrated intracranial aneurysms diagnosis strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months.
Secondary outcomes (30)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 12-month follow-up.
Rate of aneurysm rupture during patient follow-up.
Rate of aneurysm rupture is compared between intervention and control arm.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 12-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start20 May 2024
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6,450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang longjiang,MD, Jinling Hospital, China
- Investigators
- Trial Manager, Principal investigator, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118840
- Sponsor's protocol ID
- 2022NZKY-015-05
- Acronym
- IDEAL
- Status last verified
- Oct 2025
- First submitted
- 29 Aug 2022
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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: 10.1186/s13063-024-08184-9.
PubMed 38835091
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06118840
- Acronym / sponsor ID
- IDEAL / 2022NZKY-015-05
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,450 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| True-AI-integrated intracranial aneurysms diagnosis strategy | Experimental | Device: True-AI-integrated intracranial aneurysms diagnosis strategyFor 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. |
| Sham-AI-integrated intracranial aneurysms diagnosis strategy | Sham comparator | Device: Sham-AI-integrated intracranial aneurysms diagnosis strategyFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult inpatients and outpatients who are scheduled for head CTA scanning.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| True-AI-integrated intracranial aneurysms diagnosis strategyThe 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 | True-AI-integrated intracranial aneurysms diagnosis strategy |
| Sham-AI-integrated intracranial aneurysms diagnosis strategyThe 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. | Device | Sham-AI-integrated intracranial aneurysms diagnosis strategy |
Primary outcome
To compare diagnostic sensitivity of intracrnial aneurysms between intervention and control arm.
Time frame: 6 months.
The proportion of examinations in which at least one aneurysm is discovered and indicated among groundtruth aneurysms.
To compare diagnostic specificity of intracrnial aneurysms between intervention and control arm.
Time frame: 6 months.
The proportion of examinations in which no aneurysms are spotted by the reader among groundtruth non-aneurysms.
30 secondary outcomes
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.
Detection rate of no abnormality among digital subtraction angiographys (DSA) during patient follow-up.
Time frame: At 3-month and 12-month follow-up.
Distribution of the methods for aneurysms management (conservative/coil/clip/others) during patient follow-up.
Time frame: At 3-month and 12-month follow-up.
Rates of aneurysm treatment related complications during patient follow-up.
Time frame: At 3-month and 12-month follow-up.
Rate of recurrence or residual of intracranial aneurysm after surgery during patient follow-up.
Time frame: At 12-month follow-up.
Life quality assessed by EuroQol 5-Dimensional, 5-Level (EQ-5D-5L) during patient follow-up.
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 during patient follow-up.
Time frame: At 3-month and 12-month follow-up.
Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI) during patient follow-up.
Time frame: At 3-month and 12-month follow-up.
Depression Screening assessed by Patient Health Questionnaire-9 (PHQ-9) scores during patient follow-up.
Time frame: At 3-month and 12-month follow-up.
Anxiety and depression assessed by Hospital Anxiety and Depression Scale (HADS) scores during patient follow-up.
Time frame: At 3-month and 12-month follow-up.
General health assessed by Short-Form 36 Health Survey (SF-36) scores during patient follow-up.
Time frame: At 3-month and 12-month follow-up.
Functional outcome assessed by Modified Rankin Scale (mRS) scores during patient follow-up.
Time frame: At 3-month and 12-month follow-up.
All-cause mortality during patient follow-up.
Time frame: At 3-month and 12-month follow-up.
Rate of aneurysm growth during patient follow-up.
Time frame: At 12-month follow-up.
Rate of aneurysm rupture during patient follow-up.
Time frame: At 12-month follow-up.
Rate of subarachnoid hemorrhage (SAH) during patient follow-up.
Time frame: At 3-month and 12-month follow-up.
Rate of other types of stroke (hemorrhagic stroke, ischemic stroke) during patient follow-up.
Time frame: At 3-month and 12-month follow-up.
Mortality of aneurysms-rupture during patient follow-up.
Time frame: At 3-month and 12-month follow-up.
Morphological change by head CTA or magnetic resonance angiography at the 12-month follow-up.
Time frame: At 12-month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Derived from this study: PubMed 38835091Shi 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: 10.1186/s13063-024-08184-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial Manager principal investigator
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing True-AI-integrated intracranial aneurysms diagnosis strategy in people with Intracranial Aneurysm and CT Angiography, run by Jinling Hospital, China at 21 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Longjiang Zhang, MD (+8613405833176, kevinzhlj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare diagnostic sensitivity of intracrnial aneurysms between intervention and control arm. (time frame: 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06118840, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.