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

Sponsor
Tongji Hospital
Study ID
NCT07395648
Status
Not Yet Recruiting

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Conditions

  • Coronary Artery Disease
  • Myocardial Infarction

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • Smartwatch + AI assisted — DEVICE
    All patients will receive routine outpatient CR and follow-up. Subjects in the intervention group will be required to wear a smartwatch continuously for 3 months. For patients in Intervention group, the smartwatch will record the daily activities and sleep status. Furthermore, for patients in Intervention I group, the pre-trained foundation model will generate preliminary diagnostic suggestion based on the data collected by the smartwatch to remind the appearance of heart failure, myocardial ischemia, arrhythmia, abnormal blood pressure, and abnormal cerebral blood supply.
  • Smartwatch only — DEVICE
    All patients will receive routine outpatient CR and follow-up. Subjects in the intervention group will be required to wear a smartwatch continuously for 3 months. For patients in Intervention group, the smartwatch will record the daily activities and sleep status.
  • Conventional care — DEVICE
    All patients will receive routine outpatient CR and follow-up.

Study Details

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).

Key Dates

First listed
Feb 9, 2026
Start date
Apr 1, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
1,050 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Intervention I group (the smartwatch with AI assisted group)
    Subjects in the intervention group will be required to wear a smartwatch continuously for 3 months. For patients in Intervention group, the smartwatch will record the daily activities and sleep status. Furthermore, for patients in Intervention I group, the pre-trained foundation model will generate preliminary diagnostic suggestion based on the data collected by the smartwatch to remind the appearance of heart failure, myocardial ischemia, arrhythmia, abnormal blood pressure, and abnormal cerebral blood supply.
  • Experimental: Intervention II group (smartwatch assisted group)
    Subjects in the intervention group will be required to wear a smartwatch continuously for 3 months. For patients in Intervention group, the smartwatch will record the daily activities and sleep status.
  • Active Comparator: Control group ( conventional care)
    Participants will receive routine outpatient CR and follow-up.

Primary Outcome Measure

Major adverse events [ Time Frame: Three months. ]

Central Contacts

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