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

March 20, 2025 updated by: INFINITT Healthcare

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Incheon, Korea, Republic of
        • Catholic Kwandong University International St. Mary's Hospital
      • Seoul, Korea, Republic of
        • Hanyang University Seoul Hospital
    • Gyeonggi-do
      • Bucheon, Gyeonggi-do, Korea, Republic of, 16995
        • Soonchunhyang University Bucheon Hospital
      • Seongnam, Gyeonggi-do, Korea, Republic of, 16995
        • Seoul National University Bundang Hospital
      • Yongin, Gyeonggi-do, Korea, Republic of, 16995
        • Yongin Severance Hospitall, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • A patient with symptoms such as chest pain suggestive of coronary artery disease, who underwent routine evaluations including blood tests, electrocardiogram, chest X-ray, and echocardiography
  • Low to Intermediate risk of pretest probabilities of obstructive CAD
  • Voluntarily agreed to participate in this clinical trial and signed the written consent form

Exclusion Criteria:

  • Acute chest pain (in patients who have not been ruled out for ACS)
  • Previously diagnosed and treated coronary artery disease (myocardial infarction, PCI, CABG)
  • Patients with a life expectancy of less than 2 years due to conditions other than heart disease
  • Those who have not consented to the protocol
  • Participated in a drug or medical device clinical trial within the last 3 months
  • Pregnant or lactating women
  • Allergic to iodine preparations
  • Serum creatine level greater than 1.5 mg/dL or eGFR less than 30 mL/min
  • Baseline irregular and uncontrolled heart rhythm
  • Heart rate greater than 100 beats/minute
  • Systolic blood pressure of 90 mm Hg or less
  • Contraindications to beta blockers or nitroglycerin
  • Patients with complex congenital heart disease
  • Body mass index greater than or equal to 35

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Assisted by the AI-Gatekeeper software group
After a baseline examination (chest X-ray, electrocardiogram, echocardiogram, clinical risk factors and blood test), the AI-Gatekeeper software will be used to guide clinical care.
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.
No Intervention: Usual care group
The usual care group will be managed based on established guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE (major adverse cardiovascular events)
Time Frame: 24 weeks
All-cause death, non-fatal MI, stroke, admission due to acute coronary syndrome
24 weeks
Unnecessary utilization of advanced cardiac imaging
Time Frame: 24 weeks
Defined as either (1) confirmation of non-significant coronary artery disease (stenosis ≤50%) by advanced cardiac imaging (CCTA or ICA) or (2) incorrect prediction of significant CAD by the AI-Gatekeeper software.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects classified as positive by the AI-Gatekeeper model analysis who are diagnosed with coronary artery stenosis (≥50%)
Time Frame: 24 weeks
This measure assesses the accuracy of the AI-Gatekeeper model in identifying patients with coronary artery stenosis of 50% or greater among those it classifies as positive.
24 weeks
Comparison of total healthcare costs
Time Frame: 24 weeks
This analysis focuses on comparing the overall financial impact of different healthcare interventions or treatments. It encompasses all associated expenses, from diagnostic procedures to treatment and follow-up care, providing a comprehensive assessment of the economic burden on the healthcare system.
24 weeks
Comparison of changes in angina symptom score
Time Frame: 24 weeks
This comparison evaluates the variation in patients' angina symptoms severity and frequency as measured by the Seattle Angina Questionnaire (SAQ), a standardized tool for assessing chest pain related to heart conditions.
24 weeks
Proportion of subjects identified as negative by the AI-Gatekeeper model who are confirmed to have non-significant stenosis (<50%)
Time Frame: 24 weeks
This measure assesses the accuracy of the AI-Gatekeeper model in identifying patients with non-significant coronary artery stenosis (<50%) among those it classifies as negative.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

INFINITT Healthcare

Collaborators

Korea Medical Device Development Fund

Investigators

  • Principal Investigator: In Hyun Jung, MD, PhD, Yongin Severance Hospital, Yonsei University College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

September 6, 2024

Study Completion (Actual)

February 28, 2025

Study Registration Dates

First Submitted

December 14, 2023

First Submitted That Met QC Criteria

December 14, 2023

First Posted (Actual)

December 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 20, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI-Gatekeeper Pro

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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