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

Last updated: March 20, 2025
Sponsor: INFINITT Healthcare
Overall Status: Completed

Phase

N/A

Condition

Atherosclerosis

Cardiac Disease

Heart Disease

Treatment

Assisted by the AI-Gatekeeper software group

Clinical Study ID

NCT06178900
AI-Gatekeeper Pro
  • Ages 19-80
  • All Genders

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A patient with symptoms such as chest pain suggestive of coronary artery disease,who underwent routine evaluations including blood tests, electrocardiogram, chestX-ray, and echocardiography

  • Low to Intermediate risk of pretest probabilities of obstructive CAD

  • Voluntarily agreed to participate in this clinical trial and signed the writtenconsent form

Exclusion

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 thanheart 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 Design

Total Participants: 450
Treatment Group(s): 1
Primary Treatment: Assisted by the AI-Gatekeeper software group
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
February 28, 2025

Study 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.

Connect with a study center

  • Soonchunhyang University Bucheon Hospital

    Bucheon, Gyeonggi-do 16995
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam, Gyeonggi-do 16995
    Korea, Republic of

    Site Not Available

  • Yongin Severance Hospitall, Yonsei University College of Medicine

    Yongin, Gyeonggi-do 16995
    Korea, Republic of

    Site Not Available

  • Catholic Kwandong University International St. Mary's Hospital

    Incheon,
    Korea, Republic of

    Site Not Available

  • Hanyang University Seoul Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

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