NCT07395648Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 9 Feb 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1050 (estimated)
- First submitted
- 22 Jan 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Tongji Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT07395648
What you commit to
- Study type: Interventional
- Planned participants: 1050
- From 1 Apr 2026 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Coronary heart disease patients at high risk.
- 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.
Lab values
- 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;
Other
- Patients who have a pre-planned staged revascularization procedure (e.g., planned second coronary intervention) following their initial PCI for AMI.
- Tattoos or other substances that affect optical signals on the wrist.
- Pregnant women or women planning to become pregnant within the next year.
- Physical disability, blindness, and deafness.
Who the study is looking for
- Aged more than equal to 18 years, less than 69 years.
- Discharged within 6 months after PCI for acute myocardial infarction, and haven't received outpatient cardiac rehabilitation;
- 40%≤EF≤50% and NT-pro BNP ≤500 pg/mL;
- With the history of hypertension;
- Voluntarily joined and signed the informed consent.
Age in the registry: 18 years to 69 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.