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

Study acronym: SMART-CHD
StatusRecruiting
PhaseNot applicable
Started2025-08-08
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 13 months later Jul 31, 2027 → Aug 31, 2028
See other at-risk trials from China National Center for Cardiovascular Diseases

Amendment history

2026-08-16
critical
Study Status, Oversight v2
Primary completion pushed: 2027-07-31 → 2028-08-31
Completion pushed: 2027-07-31 → 2028-08-31
2025-09-18
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-07-05→confirmed 2025-08-08
Study sitesdetails revised at 16 of 16 sites
2025-06-19
minor
Original filing
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).
Trial Details
NCT Number NCT07031531
Lead Sponsor China National Center for Cardiovascular Diseases
Conditions Premature Coronary Heart Disease
Enrollment 4,900 participants
Start Date 2025-08-08
Primary Completion 2028-08-31 (estimated)
Study Completion 2028-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-18