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

Infinitt Healthcare0 个研究点目标入组 544 人开始时间: 待定最近更新: 2023年6月26日

试验速览

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•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%

•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

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