NCT06178900Completed
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
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 450 (actual)
- First submitted
- 14 Dec 2023
- Start date
- 1 Mar 2024
- Primary completion date
- 6 Sept 2024
- Lead sponsor
- INFINITT Healthcare
- Diseases
- Coronary artery disease
- NCT number
- NCT06178900
What you commit to
- Study type: Interventional
- Participants enrolled: 450
- From 1 Mar 2024 to the primary completion date, 6 Sept 2024
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously diagnosed and treated coronary artery disease (myocardial infarction, PCI, CABG)
- Participated in a drug or medical device clinical trial within the last 3 months
Other illness
- Patients with a life expectancy of less than 2 years due to conditions other than heart disease
- Allergic to iodine preparations
- Baseline irregular and uncontrolled heart rhythm
- Heart rate greater than 100 beats/minute
- Patients with complex congenital heart disease
Lab values
- Serum creatine level greater than 1.5 mg/dL or eGFR less than 30 mL/min
Other
- Acute chest pain (in patients who have not been ruled out for ACS)
- Those who have not consented to the protocol
- Pregnant or lactating women
- Systolic blood pressure of 90 mm Hg or less
- Contraindications to beta blockers or nitroglycerin
- Body mass index greater than or equal to 35
Who the study is looking for
- 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
Age in the registry: 19 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Soonchunhyang University Bucheon Hospital Coordinator of this site? Confirm its status | Bucheon-si | South Korea | Unknown status |
| Catholic Kwandong University International St.Mary's Hospital Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Hanyang University Seoul Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Yongin Severance Hospitall, Yonsei University College of Medicine Coordinator of this site? Confirm its status | Yongin | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.