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

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

Treatments tested in this trial

  • AI-Enabled Stratified Management System
  • Usual Post-Discharge Care

Treatment groups

4,900 Participants
are divided into 2 treatment groups

Locations

16
The First Affiliated Hospital of University of Science and Technology of China230001, HefeiAnhui, China
Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Diseases100037, BeijingBeijing Municipality, China
Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen518057, ShenzhenGuangdong, China
The First Hospital of Hebei Medical University050000, ShijiazhuangHebei, China

Sponsors and collaborators

China National Center for Cardiovascular Diseases

Lead sponsor