NCT07031531 Effectiveness of an AI-Enabled Stratified Management System for Premature Coronary Artery Disease
| NCT ID | NCT07031531 |
| Status | Recruiting |
| Phase | — |
| Sponsor | China National Center for Cardiovascular Diseases |
| Condition | Premature Coronary Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 4,900 participants |
| Start Date | 2025-08-08 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 4,900 participants in total. It began in 2025-08-08 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07031531 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Premature Coronary Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07031531 currently recruiting?
Yes, NCT07031531 is actively recruiting participants. Contact the research team at sophie_gao@sina.com for enrollment information.
Where is the NCT07031531 trial being conducted?
This trial is being conducted at Hefei, China, Beijing, China, Shenzhen, China, Shijiazhuang, China and 11 additional locations.
Who is sponsoring the NCT07031531 clinical trial?
NCT07031531 is sponsored by China National Center for Cardiovascular Diseases. The trial plans to enroll 4,900 participants.