None listed
Conditions
Interventions
Medical Device : The reading and analysis of the test device (AI-Gatekeeper) is carried out simultaneously with the reference standard verification and confirmation process under the supervision of th
Sponsors
Infinitt Healthcare
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Coronary artery stenosis of test device (AI Gatekeeper) based on reference standard (diameter stenosis) Check the AUC for the = 50% division. | — |
Countries
Korea, Republic of
Contacts
Public ContactIn Hyun Jung
Yonsei University Yongin Severance Hospital
Outcome results
None listed