NCT06178900

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: INFINITT Healthcare · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Coronary artery disease (CAD) is a leading cause of global mortality, accounting for over 50% of heart disease-related deaths. Initial evaluations for CAD typically involve chest X-rays, electrocardiograms (ECG), risk factor assessments, and basic blood tests. However, these primary tests can't conclusively diagnose CAD. When CAD is suspected, coronary CTA (CCTA) or invasive coronary angiography (ICA) is performed, determining the need for procedures like stenting or revascularization. Interestingly, over 50% of patients undergoing CCTA or ICA don't require treatment, as CAD is either absent or not severe enough. This leads to unnecessary procedures and significant healthcare costs. For instance, in the U.S., the cost of unnecessary ICAs reaches billions annually, with similar trends in South Korea. AI-Gatekeeper software assists clinicians in diagnosing coronary artery disease by predicting coronary artery stenosis (≥50%) using multimodal AI technology. It integrates clinical risk factors and baseline blood tests, including chest X-ray, electrocardiogram, and echocardiogram, in patients with suspected coronary artery disease The purpose of this study is to determine the efficacy, safety, and cost-effectiveness of the AI-Gatekeeper software in a prospective, multicenter, randomized control trial.

Conditions

• Coronary Artery Disease
• Diagnosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-09-06
• Completion: 2025-02-28
• First posted: 2023-12-21
• Last updated: 2025-03-24

Locations

5 sites across 1 country: South Korea