The Benefits of Wearable AI in Post-Discharge Management of AMI Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRenJi Hospital
About this trial
Myocardial infarction (MI) remains a major threat to human health. Although interventional treatment techniques have advanced rapidly, many patients still experience major adverse cardiovascular events (MACE) and require hospital readmission after discharge. Artificial intelligence (AI) based on wearable device data has shown great potential in the diagnosis and management of cardiovascular diseases.
This study aims to explore the clinical value of wearable device-based data analysis and AI-driven risk stratification models in post-discharge management of acute myocardial infarction (AMI) patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 to 75 years.
Confirmed diagnosis of acute myocardial infarction (AMI), including both ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI).
Underwent successful percutaneous coronary intervention (PCI) during index hospitalization.
Hemodynamically stable at the time of hospital discharge.
Disqualifiers
Planned staged or elective PCI or any coronary revascularization scheduled within 3 months after discharge.
Unable to tolerate or contraindicated for wearing metal or electronic monitoring devices.
Pregnant or breastfeeding women.
Residence in an area without stable network connectivity or inability to use a smartphone for data upload and communication.
Trial design
Design model
Parallel
Treatments tested in this trial
Optimized Integrated Management Based on AI-Guided Wearable Data
Combination productThe collected data will be shared with both patients and their treating physicians during follow-up visits. Based on these insights, the clinical team will offer personalized recommendations regarding medication adjustment, lifestyle modification, diet optimization, and physical activity guidance.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: The guideline-guided traditional management groupNo intervention 0 interventions
Group B: The guideline-guided and wearable-assisted management groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Time to First Unplanned Re-hospitalization event
The primary study endpoint is the time to first unplanned hospital readmission within 3 months, including readmissions due to chest pain, heart failure, arrhythmia, recurrent myocardial infarction, or death.
Time frame
From the date of hospital discharge to 3 months post-discharge (90 days).Secondary outcomes
1
Change in LVEF
LVEF will be assessed by transthoracic echocardiography at discharge (baseline) and at 3 months post-discharge follow-up. The change in LVEF will be calculated as the difference between the two measurements.
Time frame
At baseline and at 3 months post-discharge2
Change in the score of Kansas City Cardiomyopathy Questionnaire-12
The KCCQ-12, a validated patient-reported outcome measure, will be administered during the index hospitalization (prior to discharge) and again at 3 months post-discharge follow-up.
Time frame
At baseline and at 3 months post-discharge.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: