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

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).

Conditions

• Coronary Artery Disease
• Myocardial Infarction

Interventions

DEVICE

Smartwatch + AI assisted

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.

DEVICE

Smartwatch only

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.

DEVICE

Conventional care

All patients will receive routine outpatient CR and follow-up.

Sponsors & Collaborators

• Beijing Anzhen Hospital Affiliated to Capital Medical University

  collaborator UNKNOWN

• Fengtai Rehabilitation Hospital of Beijing Municipality (Tieying Hospital)

  collaborator UNKNOWN

• Beijing Aerospace General Hospital

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• The Third People's Hospital of Chengdu

  collaborator OTHER

• Second Hospital of Jilin University

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Tongji Hospital

  lead OTHER

Principal Investigators

• Cuntai Zhang, PhD · Wuhan TongJi Hospital

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

69 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-01

Primary Completion

2027-12-31

Completion

2028-06-01