The Rule-Out Acute Myocardial Infarction Using Aritifical Intelligence Electrocardiogram (ROMIAE) 2 Trial (ROMIAE 2)

July 26, 2026 updated by: Kyuseok Kim, CHA University

ROMIAE 2 Trial: Randomized Controlled Trial for Managing Suspicious Acute Myocardial Infarction in ED Using AI-ECG

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

4670

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Seoul, South Korea, 06628
        • Recruiting
        • Asan Medical Center
        • Contact:
      • Seoul, South Korea, 06628
        • Recruiting
        • Cha Bundang Medical Center
        • Contact:
      • Seoul, South Korea, 06628
        • Recruiting
        • Ewha Womans University
        • Contact:
      • Seoul, South Korea, 06628
        • Recruiting
        • Gangnam Severance Hospital
        • Contact:
      • Seoul, South Korea, 06628
        • Recruiting
        • Hanyang University
        • Contact:
      • Seoul, South Korea, 06628
        • Recruiting
        • Jeonbuk National University Hospital
        • Contact:
      • Seoul, South Korea, 06628
        • Recruiting
        • Korea University Ansan Hospital
        • Contact:
      • Seoul, South Korea, 06628
        • Recruiting
        • Korea University Guro Hospital
        • Contact:
      • Seoul, South Korea, 06628
        • Recruiting
        • Kyung Hee University Hospital
        • Contact:
      • Seoul, South Korea, 06628
        • Recruiting
        • Samsung Medical Center
        • Contact:
      • Seoul, South Korea, 06628
        • Recruiting
        • Soonchunhyang University Bucheon Hospital
        • Contact:
      • Seoul, South Korea, 06628
        • Recruiting
        • Yonsei University Wonju College of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • chest pain
  • suspicious of acute myocardial infarction

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
The patients in control group would be managed with usual care using HEART score in addition to recent acute coronary syndrome guideline.
Experimental: AI-ECG group
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.
Device: AI-ECG
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 Days MACE(Major adverse cardiac events)
Time Frame: 30 days
Death, acute myocardial infarction, stroke, target vessel revascularization, stent thrombosis within 30 days from index visit
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Missed acute myocardial infarction at index visit
Time Frame: 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)
30 days
AI-ECG 30 days MACE prediction performance
Time Frame: 30 days
AUROC and AUPRC by continuous AI-ECG score
30 days
AI-ECG 30 days MACE prediction performance
Time Frame: 30 Days
Sensitivity and specificity by pre-specified cutoff thresholds for Low to intermediate risk or intermediate to high risk
30 Days
AI-ECG 30 days MACE prediction performance
Time Frame: 30 Days
Positive predictive value and Negative predictive value by pre-specified cutoff thresholds for Low to intermediate risk or intermediate to high risk
30 Days
AI-ECG acute myocardial infarction (index visit) discrimination performance
Time Frame: 30 days
AUROC and AUPRC by continuous AI-ECG score
30 days
AI-ECG acute myocardial infarction (index visit) discrimination performance
Time Frame: 30 Days
Sensitivity and Specificity by pre-specified cutoff thresholds for Low to intermediate risk or intermediate to high risk
30 Days
AI-ECG acute myocardial infarction (index visit) discrimination performance
Time Frame: 30 Days
Positive predictive value and Negative predictive value by pre-specified cutoff thresholds for Low to intermediate risk or intermediate to high risk
30 Days
Medical resources utilization
Time Frame: 7 Days
Revisit to ED with same symptoms within 1 week
7 Days
Medical resources utilization
Time Frame: 30 days
length of stay in hospital
30 days
Medical resources utilization
Time Frame: 30 days
Length of stay in ED will be assessed both in total and according to the risk stratification by HEART score and by study period (Q1-Q4).
30 days
Medical resources utilization
Time Frame: 24 hours
Early discharge from ED(within 4 hours) will be assessed both in total and according to the risk stratification by HEART score and by study period (Q1-Q4).
24 hours
Medical resources utilization
Time Frame: 30 days
Admission rate will be assessed both in total and according to the risk stratification by HEART score and by study period (Q1-Q4).
30 days
Medical resources utilization
Time Frame: 30 days
It would be evaluated by the rate of all additional tests including cardiac CT, coronary angiography, echocardiography, and stress test. These will be assessed both in total and according to the risk stratification by HEART score and by study period (Q1-Q4).
30 days
Medical resources utilization
Time Frame: 30 days
Direct medical cost will be assessed both in total and according to the risk stratification by HEART score and by study period (Q1-Q4).
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance of medical doctor in AI-ECG low risk group
Time Frame: 7 days
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.
7 days
Compliance of medical doctor in AI-ECG low risk group
Time Frame: 7 days
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.
7 days
Compliance of medical doctor in AI-ECG low risk group
Time Frame: 7 days
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
7 days
Compliance of medical doctor in AI-ECG high risk group
Time Frame: 7 Days
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.
7 Days
Compliance of medical doctor in AI-ECG high risk group
Time Frame: 7 Days
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 the sum rate of additional tests such as coronary artery CT, CAG, stress test.
7 Days
Compliance of medical doctor in AI-ECG high risk group
Time Frame: 7 Days
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 the rate of full check up of troponin(0, 1h, 2h).
7 Days
Compliance of medical doctor in AI-ECG high risk group
Time Frame: 7 Days
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 time from ED to admission.
7 Days
Compliance of medical doctor in AI-ECG high risk group
Time Frame: 7 Days
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 time to CAG.
7 Days
Compliance of medical doctor in AI-ECG high risk group
Time Frame: 7 Days
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 cardiology contact rate.
7 Days
Satisfaction score of patients
Time Frame: 7 Days
Satisfaction score using AI-ECG from 1-10 (1 is lowest, 10 is highest)
7 Days
Satisfaction score of medical personnel
Time Frame: 7 Days
Satisfaction score using AI-ECG from 1-10 (1 is lowest, 10 is highest)
7 Days
AI-ECG occlusive myocardial infarction detection performance
Time Frame: 30 days
AUROC and AUPRC by continuous AI-ECG score
30 days
AI-ECG occlusive myocardial infarction detection performance
Time Frame: 30 days
Sensitivity and Specificity by pre-specified cutoff thresholds for Low to intermediate risk or intermediate to high risk
30 days
AI-ECG occlusive myocardial infarction detection performance
Time Frame: 30 days
Positive predictive value and Negative predictive value by pre-specified cutoff thresholds for Low to intermediate risk or intermediate to high risk
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHA University

Investigators

  • Principal Investigator: KYUSEOK Kim, MD, PhD, CHA University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

February 28, 2028

Study Registration Dates

First Submitted

May 27, 2025

First Submitted That Met QC Criteria

June 17, 2025

First Posted (Actual)

June 19, 2025

Study Record Updates

Last Update Posted (Actual)

July 28, 2026

Last Update Submitted That Met QC Criteria

July 26, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROMIAE II trial
  • RS-2025-02213791 (Other Grant/Funding Number: Korea Health Technology R&D Project)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data would be shared with other researchers when they contact to the principal investigator with reasonable context.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe