IDEAL Study: Blinded RCT for the Impact of AI Model for Cerebral Aneurysms Detection on Patients' Diagnosis and Outcomes

Last updated: October 1, 2025
Sponsor: Jinling Hospital, China
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Treatment

True-AI-integrated intracranial aneurysms diagnosis strategy

Sham-AI-integrated intracranial aneurysms diagnosis strategy

Clinical Study ID

NCT06118840
2022NZKY-015-05
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult inpatients and outpatients who are scheduled for head CTA scanning.

Exclusion

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 imagequality.

Study Design

Total Participants: 6450
Treatment Group(s): 2
Primary Treatment: True-AI-integrated intracranial aneurysms diagnosis strategy
Phase:
Study Start date:
May 20, 2024
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • The First Affiliated Hospital of University of Science and Technology of China

    Hefei, Anhui
    China

    Site Not Available

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui
    China

    Site Not Available

  • The First Affiliated Hospital of University of Science and Technology of China

    Hefei 1808722, Anhui 1818058
    China

    Active - Recruiting

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu 1791236, Anhui 1818058
    China

    Active - Recruiting

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou
    China

    Site Not Available

  • Guizhou Provincial People's Hospital

    Guiyang 1809461, Guizhou 1809445
    China

    Active - Recruiting

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Site Not Available

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou 1784658, Henan 1808520
    China

    Active - Recruiting

  • Shiyan People's Hospital

    Shiyan, Hubei
    China

    Site Not Available

  • Shiyan People's Hospital

    Shiyan 1794903, Hubei 1806949
    China

    Active - Recruiting

  • Research Institute Of Medical Imaging Jinling Hospital

    Nanjing, Jiangsu 210018
    China

    Active - Recruiting

  • Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu
    China

    Site Not Available

  • Research Institute Of Medical Imaging Jinling Hospital

    Nanjing 1799962, Jiangsu 1806260 210018
    China

    Active - Recruiting

  • Affiliated Hospital of Xuzhou Medical University

    Xuzhou 10630003, Jiangsu 1806260
    China

    Active - Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun 2038180, Jilin 2036500
    China

    Active - Recruiting

  • Shandong Provincial Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong
    China

    Site Not Available

  • Yidu Central Hospital Affiliated to Shandong Second Medical University

    Weifang, Shandong
    China

    Site Not Available

  • Shandong Provincial Hospital Affiliated to Shandong First Medical University

    Jinan 1805753, Shandong 1796328
    China

    Active - Recruiting

  • Yidu Central Hospital Affiliated to Shandong Second Medical University

    Weifang 1791681, Shandong 1796328
    China

    Active - Recruiting

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan
    China

    Site Not Available

  • The First Affiliated Hospital of Kunming Medical University

    Kunming 1804651, Yunnan 1785694
    China

    Active - Recruiting

  • Hainan General Hospital

    Haikou,
    China

    Site Not Available

  • Hainan General Hospital

    Haikou 1809078,
    China

    Active - Recruiting

  • The First People's Hospital of Kashgar Region

    Kashgar,
    China

    Site Not Available

  • The First People's Hospital of Kashgar Region

    Kashgar 1280849,
    China

    Active - Recruiting

  • University Second Hospital

    Lanzhou,
    China

    Site Not Available

  • University Second Hospital

    Lanzhou 1804430,
    China

    Active - Recruiting

  • First People's Hospital of Lianyungang

    Lianyungang,
    China

    Site Not Available

  • First People's Hospital of Lianyungang

    Lianyungang 10859300,
    China

    Active - Recruiting

  • Ma'anshan People's Hospital

    Ma'anshan,
    China

    Site Not Available

  • Ma'anshan People's Hospital

    Ma’anshan 1801620,
    China

    Active - Recruiting

  • BenQ Medical Center, Affiliated BenQ Hospital of Medical School, Nanjing Medical University

    Nanjing,
    China

    Site Not Available

  • BenQ Medical Center, Affiliated BenQ Hospital of Medical School, Nanjing Medical University

    Nanjing 1799962,
    China

    Active - Recruiting

  • Long Gang Central Hospital of Shenzhen

    Shenzhen,
    China

    Site Not Available

  • Long Gang Central Hospital of Shenzhen

    Shenzhen 1795565,
    China

    Active - Recruiting

  • The Affiliated Suqian First Hospital of Nanjing Medical University

    Suqian,
    China

    Site Not Available

  • The Affiliated Suqian First Hospital of Nanjing Medical University

    Suqian 1793771,
    China

    Active - Recruiting

  • Tianjin Medical University General Hospital

    Tianjin,
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin 1792947,
    China

    Active - Recruiting

  • General Hospital of Ningxia Medical University

    Yinchuan,
    China

    Site Not Available

  • General Hospital of Ningxia Medical University

    Yinchuan 1786657,
    China

    Active - Recruiting

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