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COMPLETED
NCT06178900
NA

Evaluating AI-Gatekeeper Software in Coronary Artery Stenosis Screening: A Multicenter RCT

Sponsor: INFINITT Healthcare

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

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