Status:
COMPLETED
Evaluating AI-Gatekeeper Software in Coronary Artery Stenosis Screening: a Multicenter RCT
Lead Sponsor:
INFINITT Healthcare
Collaborating Sponsors:
Korea Medical Device Development Fund
Conditions:
Coronary Artery Disease
Diagnosis
Eligibility:
All Genders
19-80 years
Phase:
NA
Brief 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...
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, electrocardio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2025
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT06178900
Start Date
March 1 2024
End Date
February 28 2025
Last Update
March 24 2025
Active Locations (5)
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1
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, South Korea, 16995
2
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 16995
3
Yongin Severance Hospitall, Yonsei University College of Medicine
Yongin, Gyeonggi-do, South Korea, 16995
4
Catholic Kwandong University International St. Mary's Hospital
Incheon, South Korea