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

Effectiveness of an AI-Enabled Stratified Management System for Premature Coronary Artery Disease (SMART-CHD): A Prospective, Multicenter, Open-Label, Randomized Controlled 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).

Study Overview

• Status: Recruiting
• Conditions: Premature Coronary Heart Disease
• Intervention / Treatment: Combination product: AI-Enabled Stratified Management System; Combination product: Usual Post-Discharge Care

• Study Type: Interventional
• Enrollment (Estimated): 4900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gao Prof. Gao, MD, PhD; Phone Number: 010-88322413; Email: sophie_gao@sina.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Not yet recruiting
      • The First Affiliated Hospital of University of Science and Technology of China
      • Contact: Ke Meng; Phone Number: 19995377625; Email: 19995377625@163.com
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100037
      • Recruiting
      • Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Diseases
      • Contact: Gao Prof. Gao, MD, PhD; Phone Number: +86 8832 2413; Email: sophie_gao@sina.com
  • Guangdong
    • Shenzhen, Guangdong, China, 518057
      • Not yet recruiting
      • Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
      • Contact: Fenghuan Hu, MD; Phone Number: 0755-25509566; Email: hufenghuanvip@163.com
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Not yet recruiting
      • The First Hospital of Hebei Medical University
      • Contact: Fangfang Ma; Phone Number: 13932108925; Email: fad@hebmu.edu.cn
    • Shijiazhuang, Hebei, China, 050000
      • Not yet recruiting
      • The Second Hospital Of Hebe Medical University
      • Contact: Xinshun Gu; Phone Number: 0311-66636037; Email: pub@hb2h.com
  • Henan
    • Luoyang, Henan, China, 471003
      • Not yet recruiting
      • The First Affiliated Hospital of Henan University of Science and Technology
      • Contact: Mengjuan Xu; Phone Number: 15903076908; Email: zhijuanli66@sina.com
    • Zhengzhou, Henan, China, 450000
      • Not yet recruiting
      • Henan Provincial Chest Hospital
      • Contact: Zhe Peng; Phone Number: 15538128220; Email: 15538128220@qq.com
    • Zhengzhou, Henan, China, 450000
      • Not yet recruiting
      • Zhengzhou University Affiliated Zhengzhou Central Hospital
      • Contact: Xiaojie Yang; Phone Number: 18631423366; Email: 18631423366@163.com
    • Zhengzhou, Henan, China, 450000
      • Not yet recruiting
      • Zhengzhou University Fuwai Central China Cardiovascular Hospital
      • Contact: You Zhang; Phone Number: 13932108925; Email: gaocy6802@163.com
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Not yet recruiting
      • The First Affiliated Hospital of Nanjing Medical University
      • Contact: Jiabao Liu, MD; Phone Number: 025-68303127; Email: jiabaoliu@njmu.edu.cn
    • Yangzhou, Jiangsu, China, 225001
      • Not yet recruiting
      • Northern Jiangsu People's Hospital
      • Contact: Jing Yang; Phone Number: 18512178336; Email: nyxb1980@163.com
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Not yet recruiting
      • The First Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Huan Wu, MD; Phone Number: 029-85323211; Email: 1279952786@qq.com
    • Xi'an, Shaanxi, China, 710004
      • Not yet recruiting
      • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Jie Liu; Phone Number: 029-87679000; Email: eyshce@126.com
  • Shanxi
    • Taiyuan, Shanxi, China, 030024
      • Not yet recruiting
      • Shanxi Cardiovascular Disease Hospital
      • Contact: Jingyi Liu; Phone Number: 18235123471; Email: 18235123471@163.com
  • Sichuan
    • Luzhou, Sichuan, China, 400042
      • Not yet recruiting
      • The Affiliated Hospital of Southwest Medical University
      • Contact: Ling Wu, MD; Phone Number: 0830-3165101; Email: wulingzt@163.com
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Not yet recruiting
      • The Second Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: Bingchen Liu, MD; Phone Number: 0571-87783777; Email: liubingchen111@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI-Enabled Stratified Management Group; Participants in the intervention group will use SMART-CHD alongside usual post-discharge care.	Combination product: AI-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 product: Usual Post-Discharge Care; Usual discharge protocol comprising verbal and printed discharge instructions addressing medication schedules, follow-up timelines, and lifestyle optimization strategies.
Active Comparator: Usual Post-Discharge Care Group; 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.	Combination product: Usual Post-Discharge Care; Usual discharge protocol comprising verbal and printed discharge instructions addressing medication schedules, follow-up timelines, and lifestyle optimization strategies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular Composite Endpoint Events	A composite of all-cause death, myocardial infarction, stroke, and unplanned cardiovascular-related rehospitalization.	Assessed at 12 months post-discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individual components of cardiac events	All-cause death, myocardial infarction, stroke, and unplanned cardiovascular-related rehospitalization	Assessed at 12 months post-discharge
LDL-C level	Low-density lipoprotein cholesterol level. Unit of Measure: mmol/L.	Assessed at 12 months post-discharge
LDL-C Goal Attainment	Achieving LDL-C < 1.8 mmol/L.	Assessed at 12 months post-discharge
Blood pressure level	Systolic blood pressure and Diastolic blood pressure. Unit of Measure: mmHg.	Assessed at 12 months post-discharge
Blood pressure goal attainment	Achieving target BP <130/80 mmHg.	Assessed at 12 months post-discharge
Hemoglobin A1c level	Glycated hemoglobin (HbA1c). Unit of Measure: Percentage (%).	Assessed at 12 months post-discharge
Smoking	Self-reported current smoking status. Unit of Measure: Number and percentage of current smokers	Assessed at 12 months post-discharge
Medication adherence to antiplatelet agents and statins	Adherence is defined as self-reported use of the medication for more than 80% of the time during the past month	Assessed at 12 months post-discharge

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: May 18, 2025
• First Submitted That Met QC Criteria: June 19, 2025
• First Posted (Actual): June 22, 2025

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: mobile health; artificial intelligence; secondary prevention; Premature coronary heart disease; long-term management
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Arteriosclerosis; Arterial Occlusive Diseases; Premature Birth; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2023ZD0504005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) that underlie the results reported in publications will be shared, including all collected de-identified IPD.
• IPD Sharing Time Frame: Data will be available beginning 6 months after publication of the primary results and will remain available for at least 5 years thereafter.
• IPD Sharing Access Criteria: De-identified IPD and supporting documents will be made available upon reasonable request to the Principal Investigator (PI). Requests must include a methodologically sound proposal and intended use. Access will be granted at the discretion of the PI after review of the request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No