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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorChina National Center for Cardiovascular Diseases

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with coronary heart disease aged 18-45 years;

The patient or a close family member is capable of using a smartphone and mobile application (App);

Willing to participate in the study and able to provide written informed consent.

Disqualifiers

Severe cognitive impairment;

Advanced-stage malignancy;

Life expectancy less than 12 months;

Severe multi-organ failure;

Trial design

Design model

Parallel

Treatments tested in this trial

  • AI-Enabled Stratified Management System

    Combination product

    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

    Combination product

    Usual discharge protocol comprising verbal and printed discharge instructions addressing medication schedules, follow-up timelines, and lifestyle optimization strategies.

Treatment groups

4,900 Participants
are divided into 2 treatment groups
Group A: AI-Enabled Stratified Management GroupExperimental treatment 2 interventions
Group B: Usual Post-Discharge Care GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Individual components of cardiac events

All-cause death, myocardial infarction, stroke, and unplanned cardiovascular-related rehospitalization

Time frame
Assessed at 12 months post-discharge
2

LDL-C level

Low-density lipoprotein cholesterol level. Unit of Measure: mmol/L.

Time frame
Assessed at 12 months post-discharge
3

LDL-C Goal Attainment

Achieving LDL-C \< 1.8 mmol/L.

Time frame
Assessed at 12 months post-discharge
4

Blood pressure level

Systolic blood pressure and Diastolic blood pressure. Unit of Measure: mmHg.

Time frame
Assessed at 12 months post-discharge

Other outcomes

Sponsors and contacts

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