NCT07395648

Brief 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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,050

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
23mo left

Started Apr 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Apr 2026Jun 2028

First Submitted

Initial submission to the registry

January 22, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

January 22, 2026

Last Update Submit

February 6, 2026

Conditions

Coronary Artery DiseaseMyocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Major adverse events

    Occurrence of major adverse events (MI, stroke or death)

    Three months.

Secondary Outcomes (3)

  • Motor function

    Three months

  • Quality of life

    Three months

  • Exercise tolerance

    Three months

Other Outcomes (1)

  • Major adverse cardiovascular events-1 year

    One year

Study Arms (3)

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.

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.

Device: Smartwatch only

Control group ( conventional care)

ACTIVE COMPARATOR

Participants will receive routine outpatient CR and follow-up.

Device: Conventional care

Interventions

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.

Intervention I group (the smartwatch with AI assisted group)
Conventional careDEVICE

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

Control group ( conventional care)
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.

Intervention II group (smartwatch assisted group)

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • %≤EF≤50% and NT-pro BNP ≤500 pg/mL;
  • With the history of hypertension;
  • Voluntarily joined and signed the informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial Infarction

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Cuntai Zhang, PhD

    Wuhan TongJi Hospital

    STUDY CHAIR

Central Study Contacts

Yucong Zhang, M.D.

CONTACT

86 13627115411u201110541@hust.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 22, 2026

First Posted

February 9, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

February 9, 2026

Record last verified: 2026-02