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NCT07395648
Foundation Model for Post-MI Cardiovascular Event Alert Using Huawei Watch
NA trial testing Smartwatch + AI assisted in Coronary Artery Disease in 1,050 participants. Not yet recruiting.
31 December 2027
Quick facts
| Lead sponsor | Tongji Hospital |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | health services research |
| Enrollment | 1,050 |
| Start date | 1 April 2026 |
| Primary completion | 31 December 2027 |
| Estimated completion | 1 June 2028 |
Drugs / interventions tested
- Smartwatch + AI assisted
- Smartwatch only
- Conventional care
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
- Myocardial Infarction — all drugs for Myocardial Infarction →
Sponsor
Tongji Hospital
Who can join
Adults 18 to 69, any sex, with Coronary Artery Disease or Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07395648
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07395648 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tongji Hospital
- Last refreshed: 9 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07395648.
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