The Rule-Out Acute Myocardial Infarction Using Aritifical Intelligence Electrocardiogram (ROMIAE) 2 Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCHA University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
chest pain
suspicious of acute myocardial infarction
Disqualifiers
STEMI
Revisit of same symptoms within 1 week
traumatic chest pain
Pneumothorax
Trial design
Design model
Parallel
Treatments tested in this trial
AI-ECG
DeviceThe 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.
Treatment groups
4,670 Participants
are divided into 2 treatment groupsGroup A: Control groupNo intervention 0 interventions
Group B: AI-ECG groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
30 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 daysSecondary outcomes
1
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 days2
AI-ECG 30 days MACE prediction performance
AUROC and AUPRC by continuous AI-ECG score
Time frame
30 days3
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 Days4
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 DaysOther outcomes
1
Compliance of medical doctor in AI-ECG low risk group
Compliance of medical doctors to AI-ECG results in AI-ECG low risk group according to the study period(Q1 to Q4), which would be evaluated by discharge rate from ED.
Time frame
7 days2
Compliance of medical doctor in AI-ECG low risk group
Compliance of medical doctors to AI-ECG results in AI-ECG low risk group according to the study period(Q1 to Q4), which would be evaluated by the rate of no follow-up troponin check.
Time frame
7 days3
Compliance of medical doctor in AI-ECG low risk group
Compliance of medical doctors to AI-ECG results in AI-ECG low risk group according to the study period(Q1 to Q4), which would be evaluated by the rate of only baseline and 1 h follow-up troponin check
Time frame
7 days4
Compliance of medical doctor in AI-ECG high risk group
Compliance of medical doctors to AI-ECG results in AI-ECG high risk group according to the study period(Q1 to Q4), which would be evaluated by admission rate.
Time frame
7 DaysSponsors and contacts
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Source ClinicalTrials.gov