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| Name | Class |
|---|---|
| Beijing Anzhen Hospital | OTHER |
| Fengtai Rehabilitation Hospital of Beijing Municipality (Tieying Hospital) | UNKNOWN |
| Beijing Aerospace General Hospital | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention I group (the smartwatch with AI assisted group) | Experimental | 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. |
|
| Intervention II group (smartwatch assisted group) | Experimental | 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. |
|
| Control group ( conventional care) | Active Comparator | Participants will receive routine outpatient CR and follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse events | Occurrence of major adverse events (MI, stroke or death) | Three months. |
| Measure | Description | Time Frame |
|---|---|---|
| Motor function | Assessed by metabolic equivalent of task | Three months |
| Quality of life | Assessed by 36-Item Short Form Health Survey |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular events-1 year | The occurrence of major adverse events from baseline to 1 year of follow-up | One year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yucong Zhang, M.D. | Contact | 86 13627115411 | u201110541@hust.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Cuntai Zhang, PhD | Wuhan TongJi Hospital | Study Chair |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| First Affiliated Hospital of Harbin Medical University |
| OTHER |
| The Third People's Hospital of Chengdu | OTHER |
| Second Hospital of Jilin University | OTHER |
| Qilu Hospital of Shandong University | OTHER |
| Guangdong Provincial People's Hospital | OTHER |
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| 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. |
|
| Three months |
| Exercise tolerance | Assessed by 6-minute walking distance | Three months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |