A Multi-center, Blinding, single-arm, Retrospective Pivotal Clinical Trial to evaluate the effectiveness of AI Gatekeeper, an artificial intelligence (AI)-based analysis software that aids in coronary artery disease screening

Not Applicable

Conditions: Diseases of the circulatory system

Registration Number: KCT0008516

Lead Sponsor: Infinitt Healthcare

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 544

Inclusion Criteria

1. Data of patients aged 19 years or older
2. During the period prior to IRB approval, patients visited the circulatory outpatient department with symptoms such as chest pain suspected of having coronary artery disease, and received general medical examinations and standard tests such as blood tests, electrocardiograms, chest X-rays, echocardiography, and invasive angiography. Data of patients who were finally diagnosed with coronary artery disease by performing
A. Positive data: data of patients with diameter stenosis = 50%
B. Negative data: data of patients with coronary artery diameter stenosis < 50%

Exclusion Criteria

1. Data of patients who did not satisfy the test subject selection criteria (including missing values)
2. Data of patients who have already been diagnosed with coronary artery disease or who have undergone coronary artery revascularization.
3. Data of patients without basic data such as blood test, electrocardiogram and chest X-ray imaging test, echocardiography, etc. available within 1 year before coronary angiography, which is a confirmatory test
4. Data of patients who took cardiovascular disease drugs that have an effect on coronary artery vascular blockage under the judgment of other clinicians

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Based on the reference standard, the estimated sensitivity and specificity for the diameter stenosis = 50% classification of the test device (AI-Gatekeeper) are 70% and 75% or more, respectively, and the minimum sensitivity and specificity as the lower limit of the confidence interval are clinically effective at 61% and 66% or more, respectively.

Secondary Outcome Measures