Wearable Devices Faciliate the Management of AMI Patients

NCT ID: NCT06995495

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study will explore the use of wearable technology to consistently monitor patients with acute myocardial infarction (AMI) receiving primary percutaneous coronary intervention (PCI). Parameters such as heart rate, sleep time, physical activity, and blood pressure will be collected and analyzed to characterize the patients and predict clinical outcomes.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The aim of this study is to explore in-hospital patient management and predict clinical outcomes in AMI patients receiving primary PCI through wearable technology (e.g., smart watches and wristband devices). The investigators expect to involve patients diagnosed with AMI, including ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI), who are admitted to the cardiac Cardiac Intensive Care Unit (CICU) after primary PCI.

With written consent, eligible participants will be consistently monitored by a wearable device during the CICU stay, in addition to a conventional monitoring system. Vital signs including heart rate (beats/minute), oxygen saturation (%) blood pressure (mmHg), and other crucial parameters such as sleep patterns will be recorded. The collected data will be analyzed using AI-assisted and machine learning techniques, integrated with other clinical data to construct models that support risk stratification, guide clinical decision-making, improve the quality of nursing care, and predict long-term prognosis for these patients. Serial follow-ups (6-month, annual, and long-term) will be performed, and important information such as cardiac function assessed by echocardiography, the incidence of major adverse cardiovascular events, and life qualities will be collected for each follow-up.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Aged 18-75 years old
* Diagnosed with STEMI or NSTEMI (ACC/AHA guidelines)
* Half male and half female
* Undergo CAG and PCI treatment;
* Written informed consent.

Exclusion Criteria

* People under the age of 18 years old;
* Patients who are pregnant/breastfeeding;
* Patients who are allergic to the metallic or plastic components of the wearable devices
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhiguo Zou

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Renji Hospital

Shanghai, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zhiguo Zou, MD, PhD

Role: CONTACT

+86 13524596108

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

ZHIGUO ZOU, MD, PhD

Role: primary

+86 13524596108

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EARLY-MYO Wearable Devices

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

3T MRI CIED Post-Approval Study
NCT02969395 COMPLETED
Micra Transcatheter Pacing Study
NCT02004873 COMPLETED NA