NCT07031531Recruiting
Effectiveness of an AI-Enabled Stratified Management System for Premature Coronary Artery Disease
Effectiveness of an AI-Enabled Stratified Management System for Premature Coronary Artery Disease (SMART-CHD): A Prospective, Multicenter, Open-Label, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 4900 (estimated)
- First submitted
- 18 May 2025
- Start date
- 8 Aug 2025
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Diseases
- Coronary artery disease
- NCT number
- NCT07031531
What you commit to
- Study type: Interventional
- Planned participants: 4900
- From 8 Aug 2025 to the primary completion date, 31 Aug 2028
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe cognitive impairment;
- Advanced-stage malignancy;
- Severe multi-organ failure;
Other
- Life expectancy less than 12 months;
- Refusal to provide written informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Diseases Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The Second Affiliated Hospital,School of Medicine,Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Not yet recruiting |
| The First Affiliated Hospital of University of Science and Technology of China Coordinator of this site? Confirm its status | Hefei | China | Not yet recruiting |
| The First Affiliated Hospital of Henan University of Science and Technology Coordinator of this site? Confirm its status | Luoyang | China | Not yet recruiting |
| The Affiliated Hospital of Southwest Medical University Coordinator of this site? Confirm its status | Luzhou | China | Not yet recruiting |
| The First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Not yet recruiting |
| Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen Coordinator of this site? Confirm its status | Shenzhen | China | Not yet recruiting |
| The Second Hospital Of Hebe Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Not yet recruiting |
| The First Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Not yet recruiting |
| Shanxi Cardiovascular Disease Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Not yet recruiting |
| The Second Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Not yet recruiting |
| The First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi’an | China | Not yet recruiting |
| Northern Jiangsu People's Hospital Coordinator of this site? Confirm its status | Yangzhou | China | Not yet recruiting |
| Henan Provincial Chest Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
| Zhengzhou University Affiliated Zhengzhou Central Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
| Zhengzhou University Fuwai Central China Cardiovascular Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.