Effectiveness of an AI-Enabled Stratified Management System for Premature Coronary Artery Disease (SMART-CHD): A Prospective, Multicenter, Open-Label, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,900
- 试验地点
- 16
- 主要终点
- Cardiovascular Composite Endpoint Events
研究概览
简要总结
The goal of this clinical trial is to learn if an AI-enabled stratified management system (SMART-CHD) can improve post-discharge outcomes in adults aged 18-45 with premature coronary artery disease. The main questions it aims to answer are:
- Does SMART-CHD reduce the combined rate of all-cause death, myocardial infarction, stroke and rehospitalization within 12 months?
- Does SMART-CHD achieve better control of modifiable risk factors compared with usual care?
Researchers will compare SMART-CHD to standard discharge management (verbal and printed instructions on medications, follow-up timelines and lifestyle advice) to see if the AI-driven platform leads to fewer adverse events and improved risk-factor profiles.
Participants will:
- Install and use the SMART-CHD mobile app after a 10-minute structured orientation session with supervised simulations.
- Complete regular in-app surveys on lifestyle behaviors, laboratory/imaging results and clinical events (with OCR-powered LLM assistance).
- Wear paired sensors for continuous monitoring of blood pressure, heart rate and other physiologic metrics.
- Receive automated EHR data harvesting, AI-driven voice-call reminders, and real-time CRC support via a dedicated WeChat group.
- Follow personalized, guideline-based risk-factor recommendations (diet, exercise, sleep, weight, smoking, alcohol, hypertension, dyslipidemia, diabetes).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with coronary heart disease aged 18-45 years;
- •The patient or a close family member is capable of using a smartphone and mobile application (App);
- •Willing to participate in the study and able to provide written informed consent.
排除标准
- •Severe cognitive impairment;
- •Advanced-stage malignancy;
- •Life expectancy less than 12 months;
- •Severe multi-organ failure;
- •Refusal to provide written informed consent.
研究组 & 干预措施
AI-Enabled Stratified Management Group
Participants in the intervention group will use SMART-CHD alongside usual post-discharge care.
干预措施: AI-Enabled Stratified Management System (Combination Product)
AI-Enabled Stratified Management Group
Participants in the intervention group will use SMART-CHD alongside usual post-discharge care.
干预措施: Usual Post-Discharge Care (Combination Product)
Usual Post-Discharge Care Group
Participants in the control group will receive usual discharge protocol comprising verbal and printed discharge instructions addressing medication schedules, follow-up timelines, and lifestyle optimization strategies.
干预措施: Usual Post-Discharge Care (Combination Product)
结局指标
主要结局
Cardiovascular Composite Endpoint Events
时间窗: Assessed at 12 months post-discharge
A composite of all-cause death, myocardial infarction, stroke, and unplanned cardiovascular-related rehospitalization.
次要结局
- Individual components of cardiac events(Assessed at 12 months post-discharge)
- LDL-C level(Assessed at 12 months post-discharge)
- LDL-C Goal Attainment(Assessed at 12 months post-discharge)
- Blood pressure level(Assessed at 12 months post-discharge)
- Blood pressure goal attainment(Assessed at 12 months post-discharge)
- Hemoglobin A1c level(Assessed at 12 months post-discharge)
- Smoking(Assessed at 12 months post-discharge)
- Medication adherence to antiplatelet agents and statins(Assessed at 12 months post-discharge)