Effectiveness of an AI-Enabled Stratified Management System for Premature Coronary Artery Disease (SMART-CHD)

National Center for Cardiovascular Diseases

Status: Enrolling

Conditions: Premature Coronary Heart Disease

Treatments: Combination Product: Usual Post-Discharge Care; Combination Product: AI-Enabled Stratified Management System

Study type: Interventional

Funder types: Other

Identifiers

NCT07031531

2023ZD0504005

Details and patient eligibility

About

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).

Enrollment: 4,900 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,900 participants in 2 patient groups

AI-Enabled Stratified Management Group

Experimental group

Description:

Participants in the intervention group will use SMART-CHD alongside usual post-discharge care.

Treatment:

Combination Product: AI-Enabled Stratified Management System

Combination Product: Usual Post-Discharge Care

Usual Post-Discharge Care Group

Active Comparator group

Description:

Participants in the control group will receive usual discharge protocol comprising verbal and printed discharge instructions addressing medication schedules, follow-up timelines, and lifestyle optimization strategies.

Treatment:

Combination Product: Usual Post-Discharge Care