Premature Coronary Heart Disease
Conditions
Keywords
Premature coronary heart disease, secondary prevention, long-term management, mobile health, artificial intelligence
Brief 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).
Interventions
COMBINATION_PRODUCTAI-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_PRODUCTUsual Post-Discharge Care
Usual discharge protocol comprising verbal and printed discharge instructions addressing medication schedules, follow-up timelines, and lifestyle optimization strategies.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with coronary heart disease aged 18-45 years; 2. The patient or a close family member is capable of using a smartphone and mobile application (App); 3. Willing to participate in the study and able to provide written informed consent.
Exclusion criteria
1. Severe cognitive impairment; 2. Advanced-stage malignancy; 3. Life expectancy less than 12 months; 4. Severe multi-organ failure; 5. Refusal to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Composite Endpoint Events | Assessed at 12 months post-discharge | A composite of all-cause death, myocardial infarction, stroke, and unplanned cardiovascular-related rehospitalization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Individual components of cardiac events | Assessed at 12 months post-discharge | All-cause death, myocardial infarction, stroke, and unplanned cardiovascular-related rehospitalization |
| LDL-C level | Assessed at 12 months post-discharge | Low-density lipoprotein cholesterol level. Unit of Measure: mmol/L. |
| LDL-C Goal Attainment | Assessed at 12 months post-discharge | Achieving LDL-C \< 1.8 mmol/L. |
| Blood pressure level | Assessed at 12 months post-discharge | Systolic blood pressure and Diastolic blood pressure. Unit of Measure: mmHg. |
| Blood pressure goal attainment | Assessed at 12 months post-discharge | Achieving target BP \<130/80 mmHg. |
| Hemoglobin A1c level | Assessed at 12 months post-discharge | Glycated hemoglobin (HbA1c). Unit of Measure: Percentage (%). |
| Smoking | Assessed at 12 months post-discharge | Self-reported current smoking status. Unit of Measure: Number and percentage of current smokers |
| Medication adherence to antiplatelet agents and statins | Assessed at 12 months post-discharge | Adherence is defined as self-reported use of the medication for more than 80% of the time during the past month |
Countries
China
Contacts
CONTACTGao Prof. Gao, MD, PhD
Outcome results
None listed