This study is to see whether the AI ECG assisted protocol is as safe and efficacious as conventional protocol in early triage of suspected myocardial infarction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
4,670
The patients in AI-ECG group would be managed with the information of the myocardial infarction risk score in AI-ECG in addition to the usual care.
Asan Medical Center
Seoul, South Korea
RECRUITINGCHA Bundang Medical Center
Seoul, South Korea
RECRUITING30 Days MACE(Major adverse cardiac events)
Death, acute myocardial infarction, stroke, target vessel revascularization, stent thrombosis within 30 days from index visit
Time frame: 30 days
Missed acute myocardial infarction at index visit
Missed acute myocardial infarction at index ED visit, but is detected later in anyplace (Outpatient clinic, revisit to ED, or other hospital, etc)
Time frame: 30 days
AI-ECG 30 days MACE prediction performance
AUROC and AUPRC by continuous AI-ECG score
Time frame: 30 days
AI-ECG 30 days MACE prediction performance
Sensitivity and specificity by pre-specified cutoff thresholds for Low to intermediate risk or intermediate to high risk
Time frame: 30 Days
AI-ECG 30 days MACE prediction performance
Positive predictive value and Negative predictive value by pre-specified cutoff thresholds for Low to intermediate risk or intermediate to high risk
Time frame: 30 Days
AI-ECG acute myocardial infarction (index visit) discrimination performance
AUROC and AUPRC by continuous AI-ECG score
Time frame: 30 days
AI-ECG acute myocardial infarction (index visit) discrimination performance
Sensitivity and Specificity by pre-specified cutoff thresholds for Low to intermediate risk or intermediate to high risk
Time frame: 30 Days
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Ewha Womans University
Seoul, South Korea
RECRUITINGGangnam Severance Hospital
Seoul, South Korea
RECRUITINGHanyang University
Seoul, South Korea
RECRUITINGJeonbuk National University Hospital
Seoul, South Korea
RECRUITINGKorea University Ansan Hospital
Seoul, South Korea
RECRUITINGKorea University Guro Hospital
Seoul, South Korea
RECRUITINGKyung Hee University Hospital
Seoul, South Korea
RECRUITINGSamsung Medical Center
Seoul, South Korea
RECRUITING...and 2 more locations
AI-ECG acute myocardial infarction (index visit) discrimination performance
Positive predictive value and Negative predictive value by pre-specified cutoff thresholds for Low to intermediate risk or intermediate to high risk
Time frame: 30 Days
Medical resources utilization
Length of stay in ED
Time frame: 30 days
Medical resources utilization
early discharge from ED(within 4 hours)
Time frame: 24 hours
Medical resources utilization
Revisit to ED with same symptoms within 1 week
Time frame: 7 Days
Medical resources utilization
Admission rate
Time frame: 30 days
Medical resources utilization
length of stay in hospital
Time frame: 30 days
Medical resources utilization
It would be evaluated by the rate of all additional tests including cardiac CT, coronary angiography, echocardiography, and stress test.
Time frame: 30 days
Medical resources utilization
Direct medical cost
Time frame: 30 days