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Evaluating AI-Gatekeeper Software in Coronary Artery Stenosis Screening: A Multicenter RCT
Sponsor: INFINITT Healthcare
Summary
The purpose of this study is to determine the efficacy, safety, and cost-effectiveness of AI-Gatekeeper software to assist clinicians in the diagnosis of coronary artery disease by predicting coronary artery stenosis (≥50%) from a multimodal AI technology that integrates clinical risk factors and baseline blood tests, including chest X-ray, electrocardiogram, and echocardiogram, in patients with suspected coronary artery disease (coronary stenosis).
Official title: A Prospective, Multicenter, Open-label, Randomized, Comparative Clinical Trial to Verify the Effectiveness, Safety, and Cost-effectiveness of AI-Gatekeeper, a Multimodal AI Software, in Assisting the Screening of Coronary Artery Stenosis
Key Details
Gender
All
Age Range
19 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2024-03-01
Completion Date
2025-02-28
Last Updated
2026-08-31
Healthy Volunteers
No
Conditions
Interventions
Assisted by the AI-Gatekeeper software group
The group will be received a AI-Gatekeeper software report on the probability of having coronary artery stenosis (≥50%) based on the routine test.
Locations (5)
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Yongin Severance Hospitall, Yonsei University College of Medicine
Yongin, Gyeonggi-do, South Korea
Catholic Kwandong University International St. Mary's Hospital
Incheon, South Korea
Hanyang University Seoul Hospital
Seoul, South Korea