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AI reads routine heart tests to predict artery blockages

NCT ID NCT06178900

Diagnosis Sponsor: INFINITT Healthcare Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests whether an AI software called AI-Gatekeeper can help doctors predict if a patient has significant coronary artery narrowing (at least 50% blockage) using only routine tests like blood work, ECG, chest X-ray, and echocardiogram. About 450 adults with chest pain and low to intermediate risk of heart disease will be randomly assigned to receive the AI report or not. The goal is to see if the AI reduces unnecessary advanced imaging while still catching real blockages, and whether it is safe and cost-effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AI-Gatekeeper, a multimodal AI software that analyzes routine test results to predict coronary artery stenosis
What this could lead to
If it works, this AI tool could help doctors identify patients who need advanced heart imaging, reducing unnecessary procedures and costs.
What could go wrong
The trial is still early and the AI may not be accurate enough in all patients. It also depends on routine test quality, which can vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

450 people

The number who actually took part.

Started

Mar 2024

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

coronary artery disorder disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease Diagnosis

Contacts and locations

Locations

  • Catholic Kwandong University International St. Mary's Hospital

    Incheon, South Korea

  • Hanyang University Seoul Hospital

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 16995, South Korea

  • Soonchunhyang University Bucheon Hospital

    Bucheon-si, Gyeonggi-do, 16995, South Korea

  • Yongin Severance Hospitall, Yonsei University College of Medicine

    Yongin, Gyeonggi-do, 16995, South Korea

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