Wearable Devices Faciliate the Management of AMI Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Myocardial Infarction. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Wearable Device for Characterizing AMI Patients After Primary PCI and Predicting the Clinical Outcomes
Overview
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
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.
Primary outcome measures
- Heart Rate Pattern assessed artificial intelligence (AI)-assisted analysis [Time frame: Throughout the full course of hospitalization, with an average of 1 week.]
Secondary outcome measures (5)
- Cardiac function assessed by echocardiography [Time frame: At 1-month, 6-month and 1-year follow-ups.]
- The event rate of coronary revascularization [Time frame: 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 [Time frame: 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 [Time frame: From date of enrollment until the date of follow-ups at 1-month, 6-month and 1-year post discharge.]
- Cardiovascular mortality (%) [Time frame: From date of enrollment until date of death from cardiovascular causes, or assessed up to 12 months.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Renji Hospital — Shanghai
Identifiers
NCT: NCT06995495 · EARLY-MYO Wearable Devices