NCT07031531

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

Effectiveness of an AI-Enabled Stratified Management System for Premature Coronary Artery Disease (SMART-CHD): A Prospective, Multicenter, Open-Label, Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,900 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Premature Coronary Heart Disease

Interventions

Type	Name	Description
COMBINATION_PRODUCT	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.
COMBINATION_PRODUCT	Usual Post-Discharge Care	Usual discharge protocol comprising verbal and printed discharge instructions addressing medication schedules, follow-up timelines, and lifestyle optimization strategies.

Timeline

• Start date: 2025-08-08
• Primary completion: 2027-07-31
• Completion: 2027-07-31
• First posted: 2025-06-22
• Last updated: 2025-09-23

Locations

16 sites across 1 country: China