Wearable Devices Faciliate the Management of AMI Patients
ConditionAcute Myocardial Infarction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorRenJi Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18-75 years old
Diagnosed with STEMI or NSTEMI (ACC/AHA guidelines)
Half male and half female
Undergo CAG and PCI treatment;
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
Throughout the full course of hospitalization, with an average of 1 week.Secondary outcomes
1
Cardiac function assessed by echocardiography
Cadiac function is evaluated as left ventricular ejection fraction (LVEF, %) by echocardiography
Time frame
At 1-month, 6-month and 1-year follow-ups.2
The event rate of coronary revascularization
The proportion (%) of participants who undergo an unplanned coronary revascularization procedure-either percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
Time frame
From date of enrollment until the date of follow-ups at 1-month, 6-month and 1-year post discharge.3
The event rate of heart failure
The proportion (%) of participants who experience symptomatic heart failure. Heart failure is diagnosed based on symptoms such as shortness of breath and excess fluid, in the presence of a reduced LVEF (\<60%) as assessed by echocardiography.
Time frame
From date of enrollment until the date of follow-ups at 1-month, 6-month and 1-year post discharge.4
The event rate of re-infarction
The proportion (%) of participants who experience recurrent myocardial infarction, refers to a new or additional heart attack that occurs after the myocardial infarction diagnosed at enrollment.
Time frame
From date of enrollment until the date of follow-ups at 1-month, 6-month and 1-year post discharge.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov