Actively Recruiting
Effectiveness of an AI-Enabled Stratified Management System for Premature Coronary Artery Disease (SMART-CHD): A Randomized Controlled Trial
Led by China National Center for Cardiovascular Diseases · Updated on 2025-09-23
4900
Participants Needed
16
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an AI-enabled stratified management system called SMART-CHD for adults aged 18 to 45 with premature coronary artery disease. The study aims to see if this AI-driven platform can reduce the combined rate of death, heart attack, stroke, and rehospitalization within 12 months compared with standard discharge care. It also seeks to determine if SMART-CHD better controls modifiable risk factors than usual care. Participants in the intervention group will use the SMART-CHD mobile app after a 10-minute orientation session. They will complete regular surveys on lifestyle, lab results, and clinical events using app features assisted by AI. They will also wear paired sensors for continuous monitoring of blood pressure, heart rate, and other vital signs. The system includes automated electronic health record data harvesting, AI voice-call reminders, and real-time support through a dedicated WeChat group. The app provides personalized, guideline-based recommendations on diet, exercise, sleep, weight, smoking, alcohol use, blood pressure, cholesterol, and diabetes management. The control group will receive usual discharge care with verbal and printed instructions. During the 12-month study, participants will be monitored for cardiovascular events such as death, myocardial infarction, stroke, and rehospitalization. Researchers will assess risk factor control by measuring LDL cholesterol, blood pressure, hemoglobin A1c, smoking status, and medication adherence to antiplatelet agents and statins. Data collection includes continuous sensor monitoring, in-app surveys, and automated reminders. The study will also evaluate goal attainment for blood pressure and cholesterol levels. Safety and clinical outcomes will be tracked throughout the follow-up period.
CONDITIONS
Brief Title
Effectiveness of an AI-Enabled Stratified Management System for Premature Coronary Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with coronary heart disease aged 18-45 years
- Patient or a close family member can use a smartphone and mobile application
- Willing to participate and able to provide written informed consent
You will not qualify if you...
- Severe cognitive impairment
- Advanced-stage malignancy
- Life expectancy less than 12 months
- Severe multi-organ failure
- Refusal to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 months post-discharge
Participants use either the AI-Enabled Stratified Management System alongside usual post-discharge care, or receive usual post-discharge care consisting of verbal and printed discharge instructions on medication schedules, follow-up timelines, and lifestyle strategies.
Ongoing use of the app with continuous monitoring and support or usual care instructions after discharge
Trial Site Locations
Total: 16 locations
1
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China, 230001
Not Yet Recruiting
2
Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
3
Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
Shenzhen, Guangdong, China, 518057
Not Yet Recruiting
4
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
Not Yet Recruiting
5
The Second Hospital Of Hebe Medical University
Shijiazhuang, Hebei, China, 050000
Not Yet Recruiting
6
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China, 471003
Not Yet Recruiting
7
Henan Provincial Chest Hospital
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
8
Zhengzhou University Affiliated Zhengzhou Central Hospital
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
9
Zhengzhou University Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
10
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Not Yet Recruiting
11
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China, 225001
Not Yet Recruiting
12
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710004
Not Yet Recruiting
13
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Not Yet Recruiting
14
Shanxi Cardiovascular Disease Hospital
Taiyuan, Shanxi, China, 030024
Not Yet Recruiting
15
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China, 400042
Not Yet Recruiting
16
The Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310009
Not Yet Recruiting
Research Team
G
Gao Prof. Gao, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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