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

Last updated: September 18, 2025
Sponsor: China National Center for Cardiovascular Diseases
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Disease

Cardiac Disease

Vascular Diseases

Treatment

Usual Post-Discharge Care

AI-Enabled Stratified Management System

Clinical Study ID

NCT07031531
2023ZD0504005
  • Ages 18-45
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 4900
Treatment Group(s): 2
Primary Treatment: Usual Post-Discharge Care
Phase:
Study Start date:
August 08, 2025
Estimated Completion Date:
July 31, 2027

Connect with a study center

  • The First Affiliated Hospital of University of Science and Technology of China

    Hefei, Anhui 230001
    China

    Site Not Available

  • The First Affiliated Hospital of University of Science and Technology of China

    Hefei 1808722, Anhui 1818058 230001
    China

    Site Not Available

  • Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Diseases

    Beijing, Beijing 100037
    China

    Site Not Available

  • Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Diseases

    Beijing 1816670, Beijing Municipality 2038349 100037
    China

    Active - Recruiting

  • Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen

    Shenzhen, Guangdong 518057
    China

    Site Not Available

  • Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen

    Shenzhen 1795565, Guangdong 1809935 518057
    China

    Site Not Available

  • Henan Provincial Chest Hospital

    Zhengzhou, He Nan 450000
    China

    Site Not Available

  • Zhengzhou University Affiliated Zhengzhou Central Hospital

    Zhengzhou, He Nan 450000
    China

    Site Not Available

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050000
    China

    Site Not Available

  • The Second Hospital Of Hebe Medical University

    Shijiazhuang, Hebei 050000
    China

    Site Not Available

  • The First Hospital of Hebei Medical University

    Shijiazhuang 1795270, Hebei 1808773 050000
    China

    Site Not Available

  • The Second Hospital Of Hebe Medical University

    Shijiazhuang 1795270, Hebei 1808773 050000
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan 471003
    China

    Site Not Available

  • Zhengzhou University Fuwai Central China Cardiovascular Hospital

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang 1801792, Henan 1808520 471003
    China

    Site Not Available

  • Henan Provincial Chest Hospital

    Zhengzhou 1784658, Henan 1808520 450000
    China

    Site Not Available

  • Zhengzhou University Affiliated Zhengzhou Central Hospital

    Zhengzhou 1784658, Henan 1808520 450000
    China

    Site Not Available

  • Zhengzhou University Fuwai Central China Cardiovascular Hospital

    Zhengzhou 1784658, Henan 1808520 450000
    China

    Site Not Available

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu 225001
    China

    Site Not Available

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing 1799962, Jiangsu 1806260 210029
    China

    Site Not Available

  • Northern Jiangsu People's Hospital

    Yangzhou 1787227, Jiangsu 1806260 225001
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi 710061
    China

    Site Not Available

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi 710004
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an 1790630, Shaanxi 1796480 710061
    China

    Site Not Available

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an 1790630, Shaanxi 1796480 710004
    China

    Site Not Available

  • Shanxi Cardiovascular Disease Hospital

    Taiyuan, Shanxi 030024
    China

    Site Not Available

  • Shanxi Cardiovascular Disease Hospital

    Taiyuan 1793511, Shanxi 1795912 030024
    China

    Site Not Available

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan 400042
    China

    Site Not Available

  • The Affiliated Hospital of Southwest Medical University

    Luzhou 1801640, Sichuan 1794299 400042
    China

    Site Not Available

  • The Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

  • The Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou 1808926, Zhejiang 1784764 310009
    China

    Site Not Available

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