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Effectiveness of an AI-Enabled Stratified Management System for Premature Coronary Artery Disease
Sponsor: China National Center for Cardiovascular Diseases
Summary
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).
Official title: Effectiveness of an AI-Enabled Stratified Management System for Premature Coronary Artery Disease (SMART-CHD): A Prospective, Multicenter, Open-Label, Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
4900
Start Date
2025-08-08
Completion Date
2027-07-31
Last Updated
2025-09-23
Healthy Volunteers
No
Conditions
Interventions
AI-Enabled Stratified Management System
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
Usual discharge protocol comprising verbal and printed discharge instructions addressing medication schedules, follow-up timelines, and lifestyle optimization strategies.
Locations (16)
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