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

Effect of Smartwatch Along With Foundation Model for the Monitoring and Management of Acute Myocardial Infarction Patients During Outpatient Cardiac Rehabilitation After Percutaneous Coronary Intervention: Protocol for a Randomised Controlled Multicentre Trial

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Myocardial Infarction; Coronary Artery Disease
• Intervention / Treatment: Device: Smartwatch + AI assisted; Device: Smartwatch only; Device: Conventional care

• Study Type: Interventional
• Enrollment (Estimated): 1050
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yucong Zhang, M.D.; Phone Number: 86 13627115411; Email: u201110541@hust.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged more than equal to 18 years, less than 69 years.
2. Discharged within 6 months after PCI for acute myocardial infarction, and haven't received outpatient cardiac rehabilitation;
3. 40%≤EF≤50% and NT-pro BNP ≤500 pg/mL;
4. With the history of hypertension;
5. Voluntarily joined and signed the informed consent.

Exclusion Criteria:

1. With contraindication for rehabilitation activities include: unstable angina, uncontrolled hypertension (systolic blood pressure>180 mmHg and/or diastolic blood pressure>110 mmHg in a quiet state), severe symptomatic heart valve stenosis, uncontrolled heart rate increase (>130 beats/minute), uncontrolled heart failure, third degree atrioventricular block (without pacemaker implantation), active pericarditis or myocarditis, presence of newly formed embolism (pulmonary or systemic circulation), aortic dissection, acute thrombophlebitis, acute systemic disease or fever, other metabolic abnormalities (such as acute thyroiditis, electrolyte imbalance, uncorrected blood glucose abnormalities or insufficient blood volume), and severe psychological disorders;
2. Patients who have a pre-planned staged revascularization procedure (e.g., planned second coronary intervention) following their initial PCI for AMI.
3. Tattoos or other substances that affect optical signals on the wrist.
4. Coronary heart disease patients at high risk.
5. Pregnant women or women planning to become pregnant within the next year.
6. Severe arrhythmia, including third degree atrioventricular block, ventricular escape rhythm, severe sinus bradycardia, sick sinus syndrome, supraventricular tachycardia, ventricular tachycardia, atrial fibrillation, atrial flutter, ventricular fibrillation, ventricular flutter.
7. Physical disability, blindness, and deafness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.
Active Comparator: Control group ( conventional care); Participants will receive routine outpatient CR and follow-up.	Device: Conventional care; All patients will receive routine outpatient CR and follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse events	Occurrence of major adverse events (MI, stroke or death)	Three months.

Secondary Outcome Measures

Outcome Measure	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	Three months
Exercise tolerance	Assessed by 6-minute walking distance	Three months

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Collaborators: Qilu Hospital of Shandong University; Guangdong Provincial People's Hospital; Second Hospital of Jilin University; First Affiliated Hospital of Harbin Medical University; Beijing Aerospace General Hospital; The Third People's Hospital of Chengdu; Beijing Anzhen Hospital Affiliated to Capital Medical University; Fengtai Rehabilitation Hospital of Beijing Municipality (Tieying Hospital)
• Investigators: Study Chair: Cuntai Zhang, PhD, Wuhan Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Coronary Artery Disease; Myocardial Infarction
• Other Study ID Numbers: 2025S128

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No