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

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Diseases
RECRUITING
Beijing
The Second Affiliated Hospital, School of Medicine, Zhejiang University
NOT_YET_RECRUITING
Hangzhou
The First Affiliated Hospital of University of Science and Technology of China
NOT_YET_RECRUITING
Hefei
The First Affiliated Hospital of Henan University of Science and Technology
NOT_YET_RECRUITING
Luoyang
The Affiliated Hospital of Southwest Medical University
NOT_YET_RECRUITING
Luzhou
The First Affiliated Hospital of Nanjing Medical University
NOT_YET_RECRUITING
Nanjing
Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
NOT_YET_RECRUITING
Shenzhen
The First Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
The Second Hospital Of Hebe Medical University
NOT_YET_RECRUITING
Shijiazhuang
Shanxi Cardiovascular Disease Hospital
NOT_YET_RECRUITING
Taiyuan
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
The Second Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
Northern Jiangsu People's Hospital
NOT_YET_RECRUITING
Yangzhou
Henan Provincial Chest Hospital
NOT_YET_RECRUITING
Zhengzhou
Zhengzhou University Affiliated Zhengzhou Central Hospital
NOT_YET_RECRUITING
Zhengzhou
Zhengzhou University Fuwai Central China Cardiovascular Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Gao Prof. Gao, MD, PhD
sophie_gao@sina.com
010-88322413
Time Frame
Start Date: 2025-08-08
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 4900
Treatments
Experimental: AI-Enabled Stratified Management Group
Participants in the intervention group will use SMART-CHD alongside usual post-discharge care.
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.
Sponsors
Leads: China National Center for Cardiovascular Diseases

This content was sourced from clinicaltrials.gov