Clinical Trial

Foundation Model for Post-MI Cardiovascular Event Alert Using Huawei Watch

Not Yet Recruiting
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Summary
The goal of this randomized controlled trial is to evaluate whether a HUAWEI smartwatch integrated with a foundation model can enhance daily monitoring and management of AMI patients during outpatient cardiac rehabilitation after PCI. Can a HUAWEI smartwatch with a foundation model improve daily monitoring/management of post-PCI AMI patients during 3-month outpatient CR, vs routine management or smartwatch without AI? Does the AI-enabled smartwatch (Intervention I) reduce 3-month cardiovascular-related hospital/emergency visits vs the other two groups? Do smartwatches (with/without AI) enhance quality of life and activity function post 3-month CR? Does the AI-enabled smartwatch lower 1-year major adverse cardiovascular events (MACEs) and related hospital/emergency visits vs other groups? How accurate is the AI-enabled smartwatch's alert system (vs hospital diagnostic results) for cardiovascular abnormalities? What is the usability of the AI-enabled smartwatch for patients and doctors? Participants will: Sign informed consent; complete baseline exams (MET, SF-36, 6-minute walk, exercise tolerance test) and questionnaires (demographics, medical history, medications). Receive 3-month outpatient CR. Attend follow-ups; report all adverse events promptly. Intervention I (AI-Enabled Smartwatch) group Wear the smartwatch continuously for 3 months (sleep wear recommended); actively collect ≥30s ECG via the watch's crown. Pause activity if heart rate exceeds anaerobic threshold; adjust exercise intensity if METs mismatch prescription. Contact doctors immediately upon receiving abnormality alerts (e.g., heart failure); follow expert recommendations for further care; complete usability questionnaires. Intervention II (Non-AI Smartwatch) group Wear the smartwatch continuously for 3 months (sleep wear recommended) to track activity/sleep, monitor real-time heart rate/MET. Pause activity if heart rate exceeds anaerobic threshold; adjust exercise intensity if METs mismatch prescription. Control Group Complete routine outpatient CR and follow-ups (no smartwatch use).
Trial Details
NCT Number NCT07395648
Lead Sponsor Tongji Hospital
Collaborators: Beijing Anzhen Hospital, Fengtai Rehabilitation Hospital of Beijing Municipality (Tieying Hospital), Beijing Aerospace General Hospital, First Affiliated Hospital of Harbin Medical University, The Third People's Hospital of Chengdu, Second Hospital of Jilin University, Qilu Hospital of Shandong University, Guangdong Provincial People's Hospital
Conditions Coronary Artery Disease, Myocardial Infarction
Enrollment 1,050 participants
Start Date 2026-04-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-09