Coronary Artery DiseaseNCT07395648
Foundation Model for Post-MI Cardiovascular Event Alert Using Huawei Watch
A study testing Smartwatch + AI assisted, Smartwatch only and Conventional care in people with Coronary Artery Disease and Myocardial Infarction, run by Tongji Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Coronary Artery Disease, Myocardial Infarction
- What is being tested?
- Smartwatch + AI assisted, Smartwatch only and Conventional care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- 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.
- Coronary heart disease patients at high risk.
- Pregnant women or women planning to become pregnant within the next year.
- 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.
- Physical disability, blindness, and deafness.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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?
Read more
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
- Being tested
- Smartwatch + AI assisted, Smartwatch only, Conventional care
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartwatch + AI assistedDevice
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 onlyDevice
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 careDevice
All patients will receive routine outpatient CR and follow-up.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Smartwatch + AI assisted |
| 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. Receives: Device: Smartwatch only |
| Control group ( conventional care) | Active comparator | Participants will receive routine outpatient CR and follow-up. Receives: Device: Conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse events
Occurrence of major adverse events (MI, stroke or death)
Measured: Three months.
Secondary outcomes (3)
Motor function
Assessed by metabolic equivalent of task
Measured: Three months
Quality of life
Assessed by 36-Item Short Form Health Survey
Measured: Three months
Exercise tolerance
Assessed by 6-minute walking distance
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Anzhen Hospital, Fengtai Rehabilitation Hospital of Beijing Municipality (Tieying Hospital), Beijing Aerospace General Hospital, First Affiliated Hospital of Harbin Medical University, The Third People's Hospital of Chengdu, Second Hospital of Jilin University, Qilu Hospital of Shandong University, Guangdong Provincial People's Hospital
- Responsible party
- Principal investigator, Zhang Cuntai, Tongji Hospital
- Investigators
- Cuntai Zhang, PhD, Study chair, Wuhan TongJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395648
- Sponsor's protocol ID
- 2025S128
- Status last verified
- Feb 2026
- First submitted
- 22 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07395648
- Acronym / sponsor ID
- 2025S128
- Conditions
- Coronary Artery Disease, Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Beijing Anzhen Hospital, Fengtai Rehabilitation Hospital of Beijing Municipality (Tieying Hospital), Beijing Aerospace General Hospital, First Affiliated Hospital of Harbin Medical University, The Third People's Hospital of Chengdu, Second Hospital of Jilin University, Qilu Hospital of Shandong University, Guangdong Provincial People's Hospital
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention I group (the smartwatch with AI assisted group) | Experimental | Device: Smartwatch + AI assistedSubjects 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 | Device: Smartwatch onlySubjects 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 | Device: Conventional careParticipants will receive routine outpatient CR and follow-up. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
- 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.
- Coronary heart disease patients at high risk.
- Pregnant women or women planning to become pregnant within the next year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartwatch + AI assistedAll 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 | Intervention I group (the smartwatch with AI assisted group) |
| Smartwatch onlyAll 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 | Intervention II group (smartwatch assisted group) |
| Conventional careAll patients will receive routine outpatient CR and follow-up. | Device | Control group ( conventional care) |
Primary outcome
Major adverse events
Time frame: Three months.
Occurrence of major adverse events (MI, stroke or death)
3 secondary outcomes
Motor function
Time frame: Three months
Quality of life
Time frame: Three months
Exercise tolerance
Time frame: Three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cuntai Zhang, PhD study chair
Wuhan TongJi Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Smartwatch + AI assisted, Smartwatch only and Conventional care in people with Coronary Artery Disease and Myocardial Infarction, run by Tongji Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yucong Zhang, M.D. (86 13627115411, u201110541@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse events (time frame: Three months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.