The Rule-Out Acute Myocardial Infarction Using Aritifical Intelligence Electrocardiogram (ROMIAE) 2 Trial
- Conditions
- Myocardial Infarction (MI)Chest Pain Rule Out Myocardial Infarction
- Registration Number
- NCT07027891
- Lead Sponsor
- CHA University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 4670
- chest pain
- suspicious of acute myocardial infarction
- STEMI
- Revisit of same symptoms within 1 week
- traumatic chest pain
- Pneumothorax
- Transferred from other hospital diagnosed of AMI
- Cardiac arrest
- Chest pain of clearly non-cardiac etiology
- declined to participate in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 30 Days MACE(Major adverse cardiac events) 30 days Death, acute myocardial infarction, stroke, target vessel revascularization, stent thrombosis within 30 days from index visit
- Secondary Outcome Measures
Name Time Method Missed acute myocardial infarction at index visit 30 days Missed acute myocardial infarction at index ED visit, but is detected later in anyplace (Outpatient clinic, revisit to ED, or other hospital, etc)
AI-ECG 30 days MACE prediction performance 30 Days Positive predictive value and Negative predictive value by pre-specified cutoff thresholds for Low to intermediate risk or intermediate to high risk
AI-ECG acute myocardial infarction (index visit) discrimination performance 30 Days Positive predictive value and Negative predictive value by pre-specified cutoff thresholds for Low to intermediate risk or intermediate to high risk
Medical resources utilization 30 days Direct medical cost