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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
4,900
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 discharge protocol comprising verbal and printed discharge instructions addressing medication schedules, follow-up timelines, and lifestyle optimization strategies.
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
NOT_YET_RECRUITINGFuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, China
RECRUITINGFuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
Shenzhen, Guangdong, China
NOT_YET_RECRUITINGThe First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
NOT_YET_RECRUITINGThe Second Hospital Of Hebe Medical University
Shijiazhuang, Hebei, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
NOT_YET_RECRUITINGHenan Provincial Chest Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGZhengzhou University Affiliated Zhengzhou Central Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGZhengzhou University Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
NOT_YET_RECRUITING...and 6 more locations
Cardiovascular Composite Endpoint Events
A composite of all-cause death, myocardial infarction, stroke, and unplanned cardiovascular-related rehospitalization.
Time frame: Assessed at 12 months post-discharge
Individual components of cardiac events
All-cause death, myocardial infarction, stroke, and unplanned cardiovascular-related rehospitalization
Time frame: Assessed at 12 months post-discharge
LDL-C level
Low-density lipoprotein cholesterol level. Unit of Measure: mmol/L.
Time frame: Assessed at 12 months post-discharge
LDL-C Goal Attainment
Achieving LDL-C \< 1.8 mmol/L.
Time frame: Assessed at 12 months post-discharge
Blood pressure level
Systolic blood pressure and Diastolic blood pressure. Unit of Measure: mmHg.
Time frame: Assessed at 12 months post-discharge
Blood pressure goal attainment
Achieving target BP \<130/80 mmHg.
Time frame: Assessed at 12 months post-discharge
Hemoglobin A1c level
Glycated hemoglobin (HbA1c). Unit of Measure: Percentage (%).
Time frame: Assessed at 12 months post-discharge
Smoking
Self-reported current smoking status. Unit of Measure: Number and percentage of current smokers
Time frame: Assessed at 12 months post-discharge
Medication adherence to antiplatelet agents and statins
Adherence is defined as self-reported use of the medication for more than 80% of the time during the past month
Time frame: Assessed at 12 months post-discharge
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