Effectiveness of an AI-Enabled Stratified Management System for Premature Coronary Artery Disease

Description

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: 1. Does SMART-CHD reduce the combined rate of all-cause death, myocardial infarction, stroke and rehospitalization within 12 months? 2. 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: 1. Install and use the SMART-CHD mobile app after a 10-minute structured orientation session with supervised simulations. 2. Complete regular in-app surveys on lifestyle behaviors, laboratory/imaging results and clinical events (with OCR-powered LLM assistance). 3. Wear paired sensors for continuous monitoring of blood pressure, heart rate and other physiologic metrics. 4. Receive automated EHR data harvesting, AI-driven voice-call reminders, and real-time CRC support via a dedicated WeChat group. 5. Follow personalized, guideline-based risk-factor recommendations (diet, exercise, sleep, weight, smoking, alcohol, hypertension, dyslipidemia, diabetes).

Interventions

• AI-Enabled Stratified Management System (Combination product)
  After discharge, participants install SMART-CHD, sync their EHR data, and complete a 10-minute orientation. They then use the app's OCR-assisted surveys to report lifestyle, lab, and event data, while paired wearables stream continuous vitals. AI voice calls and a CRC-managed WeChat group deliver reminders and support. The app's embedded predictive models stratify them into risk tiers and generate tier-specific follow-up schedules. Personalized lifestyle modification guidance, dietary plans, and medication adjustment recommendations are generated by the platform's module. Automated alerts and teleconsultation options are triggered upon detection of high-risk signs or abnormal results, ensuring timely clinical intervention and enhanced secondary prevention.
• Usual Post-Discharge Care (Combination product)
  Usual discharge protocol comprising verbal and printed discharge instructions addressing medication schedules, follow-up timelines, and lifestyle optimization strategies.

Eligibility criteria

Conditions

Locations

• The First Affiliated Hospital of University of Science and Technology of China — Hefei, Anhui, China
• Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Diseases — Beijing, Beijing Municipality, China
• Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen — Shenzhen, Guangdong, China
• The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, China
• The Second Hospital Of Hebe Medical University — Shijiazhuang, Hebei, China
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China
• Henan Provincial Chest Hospital — Zhengzhou, Henan, China
• Zhengzhou University Affiliated Zhengzhou Central Hospital — Zhengzhou, Henan, China
• Zhengzhou University Fuwai Central China Cardiovascular Hospital — Zhengzhou, Henan, China
• The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China
• Northern Jiangsu People's Hospital — Yangzhou, Jiangsu, China
• The Second Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China
• Shanxi Cardiovascular Disease Hospital — Taiyuan, Shanxi, China
• The Affiliated Hospital of Southwest Medical University — Luzhou, Sichuan, China
• The Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China