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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 10
- 主要终点
- MACE (major adverse cardiovascular events)
研究概览
简要总结
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).
详细描述
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, electrocardiograms (ECG), risk factor assessments, and basic blood tests. However, these primary tests can't conclusively diagnose CAD. When CAD is suspected, coronary CTA (CCTA) or invasive coronary angiography (ICA) is performed, determining the need for procedures like stenting or revascularization.
Interestingly, over 50% of patients undergoing CCTA or ICA don't require treatment, as CAD is either absent or not severe enough. This leads to unnecessary procedures and significant healthcare costs. For instance, in the U.S., the cost of unnecessary ICAs reaches billions annually, with similar trends in South Korea.
AI-Gatekeeper software assists clinicians in diagnosing coronary artery disease by predicting coronary artery stenosis (≥50%) using multimodal AI technology. It integrates clinical risk factors and baseline blood tests, including chest X-ray, electrocardiogram, and echocardiogram, in patients with suspected coronary artery disease The purpose of this study is to determine the efficacy, safety, and cost-effectiveness of the AI-Gatekeeper software in a prospective, multicenter, randomized control trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Assisted by the AI-Gatekeeper software group
After a baseline examination (chest X-ray, electrocardiogram, echocardiogram, clinical risk factors and blood test), the AI-Gatekeeper software will be used to guide clinical care.
干预措施: Assisted by the AI-Gatekeeper software group (Diagnostic Test)
Usual care group
The usual care group will be managed based on established guidelines.
结局指标
主要结局
MACE (major adverse cardiovascular events)
时间窗: 24 weeks
All-cause death, non-fatal MI, stroke, admission due to acute coronary syndrome
Unnecessary utilization of advanced cardiac imaging
时间窗: 24 weeks
Confirmation of non-obstructive coronary artery disease (diameter stenosis ≤50%) by advanced cardiac imaging (CCTA or ICA)
次要结局
- Comparison of total healthcare costs(24 weeks)
- Proportion of subjects classified as positive by the AI-Gatekeeper model analysis who are diagnosed with coronary artery stenosis (≥50%)(24 weeks)
- Proportion of subjects identified as negative by the AI-Gatekeeper model who are confirmed to have non-significant stenosis (<50%)(24 weeks)
- Comparison of changes in angina symptom score(24 weeks)
- MACE (major adverse cardiovascular events)(24 weeks)