AI-guided post-discharge care 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
This trial will test whether an AI-powered app and stratified management system can lower deaths, heart attacks, strokes, and rehospitalizations and improve risk-factor control in adults aged 18–45 with premature coronary artery disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 4900 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 16 sites (Hefei, Anhui and 15 other locations) |
| Trial ID | NCT07031531 on ClinicalTrials.gov |
What this trial studies
Researchers will compare an AI-enabled stratified management platform (SMART-CHD) to usual post-discharge care to see if the digital approach reduces a combined endpoint of all-cause death, myocardial infarction, stroke, and rehospitalization within 12 months and improves control of modifiable risk factors. Participants assigned to SMART-CHD install the mobile app after a brief supervised orientation and complete regular in-app surveys on lifestyle, labs, imaging, and clinical events, with OCR-enabled language models to capture results. The control group receives standard verbal and printed discharge instructions on medications, follow-up, and lifestyle advice. Outcomes are measured over a 12-month follow-up period to compare event rates and risk-factor trajectories between groups.
Who should consider this trial
Good fit: Adults aged 18–45 with diagnosed coronary heart disease who can use a smartphone (or have a family member who can) and are willing to provide written informed consent are ideal candidates.
Not a fit: Patients with severe cognitive impairment, advanced cancer, life expectancy under 12 months, severe multi-organ failure, inability or refusal to consent, or no access to a smartphone are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the system could reduce serious cardiovascular events and rehospitalizations while improving long-term risk-factor control for younger adults with premature coronary disease.
How similar studies have performed: Mobile health and digital cardiac care programs have shown modest improvements in adherence and risk-factor control in cardiac populations, but AI-driven stratified post-discharge systems remain relatively novel and not widely validated for young-onset coronary disease.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hefei, Anhui and 15 other locations
- The First Affiliated Hospital of University of Science and Technology of China — Hefei, Anhui, China (Not_yet_recruiting)
- Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Diseases — Beijing, Beijing Municipality, China (Recruiting)
- Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen — Shenzhen, Guangdong, China (Not_yet_recruiting)
- The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Not_yet_recruiting)
- The Second Hospital Of Hebe Medical University — Shijiazhuang, Hebei, China (Not_yet_recruiting)
- The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China (Not_yet_recruiting)
- Henan Provincial Chest Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
- Zhengzhou University Affiliated Zhengzhou Central Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
- Zhengzhou University Fuwai Central China Cardiovascular Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
- The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Not_yet_recruiting)
- Northern Jiangsu People's Hospital — Yangzhou, Jiangsu, China (Not_yet_recruiting)
- The Second Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (Not_yet_recruiting)
- The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (Not_yet_recruiting)
- Shanxi Cardiovascular Disease Hospital — Taiyuan, Shanxi, China (Not_yet_recruiting)
- The Affiliated Hospital of Southwest Medical University — Luzhou, Sichuan, China (Not_yet_recruiting)
- The Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Gao Prof. Gao, MD, PhD
- Email: sophie_gao@sina.com
- Phone: 010-88322413
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.