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

NCT06178900 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2025-03-24

No results posted yet for this study

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).

Conditions

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.

Sponsors & Collaborators

  • Korea Medical Device Development Fund

    collaborator UNKNOWN

  • INFINITT Healthcare

    lead INDUSTRY

Principal Investigators

  • In Hyun Jung, MD, PhD · Yongin Severance Hospital, Yonsei University College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2024-09-06
Completion
2025-02-28

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06178900 on ClinicalTrials.gov