ROMIAE (Rule-Out Acute Myocardial Infarction Using Artificial Intelligence Electrocardiogram Analysis) Trial

Study Overview
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Brief Summary
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This study is a prospective multicenter observational study for external validation and model advancement of a deep learning based 12-lead electrocardiogram analysis algorithm targeting adult patients presenting to the emergency department with chest pain and acute myocardial infarction equivalent symptoms. About 9,000 adult patients will be enrolled at 20 emergency medical centers in Korea. Artificial intelligence algorithms are manufactured by Medical AI Co., Ltd. It is an advanced version based on the model developed and published in 2020. It had the diagnostic performance of area under the receiver operating curve 0.901 and 0.951 for acute myocardial infarction and ST-segment elevation myocardial infarction, respectively. The primary endpoint is a diagnosis of acute myocardial infarction on the day of the emergency center visit, and the secondary endpoint is a 30-day major adverse cardiac event. From March 2022, patient registration will begin at centers that have been approved by the Institutional Review Board. This is the first prospective multicenter emergency department validation study for a 12-lead electrocardiogram artificial intelligence algorithm to diagnose acute myocardial infarction. This study will give insight into the direction of future development by verifying whether the deep learning algorithm works well for patients visiting the real-world adult emergency medical center.

Official Title
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A Prospective, Multicenter, Observational Diagnostic Study to Externally Validate an Artificial Intelligence 12-lead Electrocardiogram Analysis Algorithm to Detect Patients With Acute Myocardial Infarction Who Visit Emergency Medical Center

Conditions
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Myocardial Infarction or Chest Pain

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults over 18 years of age with suspected chest pain and acute myocardial infarction The onset or worsening of the symptom occurs within 24 hours Exclusion Criteria: Out-of-hospital cardiac arrest (OHCA): patients with sustained (>20 minutes) return-of-spontaneous-circulation are not excluded Patients in whom acute myocardial infarction can be clearly excluded, such as pneumothorax and traumatic chest pain

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Patients with chest pain or who are clinically suspected as acute myocardial infarction with equivalent symptoms. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of acute myocardial infarction (Type 1, 2) | Accuracy metrics include area under the receiver operating characteristics curve, sensitivity, specificity, positive predictive value, and negative predictive value, along with a 95% confidence interval. | Index admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular event (MACE) | MACE is defined as death, myocardial infarction, stroke, target-vessel revascularization, or stent thrombosis occurring within 30 days of index visit. Accuracy metrics include area under the receiver operating characteristics curve, sensitivity, specificity, positive predictive value, and negative predictive value, along with a 95% confidence interval. | 30-day after index admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep Learning