Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
All Genders
NCT07031531

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

Led by China National Center for Cardiovascular Diseases · Updated on 2025-09-23

4900

Participants Needed

16

Research Sites

103 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 45Years
All Genders

Eligibility Criteria

Eligible

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 app
  • Willing to participate and able to provide written informed consent
Not Eligible

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

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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

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Research Team

G

Gao Prof. Gao, MD, PhD

CONTACT

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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