NCT06772337

Effect of Digital Therapeutics for Cardiac Rehabilitation in Patients With Acute Myocardial Infarction

the Risk Prediction Model of Major Adverse Cardiovascular Events After PCI in Patients With Acute Myocardial Infarction Based on Multimodal Machine Learning and the Effect of Digital Therapeutics for Cardiac Rehabilitation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study adopts a multicenter, open-label, randomized controlled clinical study, with Jiangsu Provincial People's Hospital as the leading unit, and the other 13 hospitals as cooperative units.

Detailed description

It uniformly deploys an integrated cardiac rehabilitation management platform from the hospital to outside the hospital. Based on this platform, precise cardiac rehabilitation for myocardial infarction patients based on continuous dynamic physiological data is carried out. A total of 160 myocardial infarction patients after PCI who will undergo digital therapy cardiac rehabilitation are randomly divided into a digital cardiac rehabilitation group (experimental group) and a conventional treatment group (control group) at a ratio of 1:1 using a computer random sequence method, with 80 patients included in each group.

Conditions

• Acute Myocardial Infarction
• Cardiac Rehabilitation

Interventions

Type	Name	Description
BEHAVIORAL	digital cardiac rehabilitation	Intra-hospital cardiac rehabilitation: For patients after PCI, reasonable dietary intervention, conventional drug treatment and conventional rehabilitation are given, without lower extremity power bike and respiratory training.Outside-hospital cardiac rehabilitation: The experimental group received conventional treatment and secondary prevention drugs recommended by the current guidelines, and carried out supervised digital cardiac rehabilitation on this basis.Doctors prescribe progressive aerobic exercise (walking) through mobile phone apps or computer terminals. Patients will train with wearable devices that can monitor physiological parameters in real time through the mobile phone FREE Rehabilitation APP.
BEHAVIORAL	Regular Treatment	Intra-hospital cardiac rehabilitation: For patients after PCI, reasonable dietary intervention, conventional drug treatment and conventional rehabilitation are given, without lower extremity power bike and respiratory training.Out-of-hospital cardiac rehabilitation: Receiving conventional treatment and secondary prevention drugs recommended by current guidelines, nutritional diet and lifestyle guidance, and establishing a WeChat group as a postoperative follow-up contact method.Outside-hospital cardiac rehabilitation: The experimental group received conventional treatment and secondary prevention drugs recommended by the current guidelines, and carried out supervised digital cardiac rehabilitation on this basis.Doctors prescribe progressive aerobic exercise (walking) through mobile phone apps or computer terminals. Patients will train with wearable devices that can monitor physiological parameters in real time through the mobile phone FREE Rehabilitation APP.

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2025-01-13
• Last updated: 2025-01-13

Locations

1 site across 1 country: China