Wearable Devices Faciliate the Management of AMI Patients

NCT06995495 | Recruiting

• 1 other identifier: EARLY-MYO Wearable Devices
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Heart Rate Pattern assessed artificial intelligence (AI)-assisted analysis

  The dynamic trajectory or trend of a patient's heart rate measurements over the course of hospital stay. Time series data will be analyzed by AI-assisted machine learning model.

  Throughout the full course of hospitalization, with an average of 1 week.

Secondary Outcomes (5)

• Cardiac function assessed by echocardiography

  At 1-month, 6-month and 1-year follow-ups.

• The event rate of coronary revascularization

  From date of enrollment until the date of follow-ups at 1-month, 6-month and 1-year post discharge.

• The event rate of heart failure

  From date of enrollment until the date of follow-ups at 1-month, 6-month and 1-year post discharge.

• The event rate of re-infarction

  From date of enrollment until the date of follow-ups at 1-month, 6-month and 1-year post discharge.

• Cardiovascular mortality (%)

  From date of enrollment until date of death from cardiovascular causes, or assessed up to 12 months.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are diagnosed with AMI, including ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI), and admitted to cardiac Cardiac Intensive Care Unit (CICU) after primary PCI.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, 200127, China

RECRUITING

Central Study Contacts

Zhiguo Zou, MD, PhD

CONTACT

+86 13524596108; zouzhiguo@renji.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: May 29, 2025
• Study Start: April 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

CN (1)