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

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: Myocardial Infarction (MI); Chest Pain Rule Out Myocardial Infarction
• Intervention / Treatment: Device: AI-ECG

• Study Type: Interventional
• Enrollment (Estimated): 4670
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kyuseok Kim, MD, PhD; Phone Number: +821047808321; Email: dreinstein70@gmail.com

Study Locations

• South Korea
  • Seoul, South Korea, 06628
    • Recruiting
    • Asan Medical Center
    • Contact: Won Young Kim; Phone Number: 01072715938; Email: wonpia73@naver.com
  • Seoul, South Korea, 06628
    • Recruiting
    • CHA Bundang Medical Center
    • Contact: Kyuseok Kim; Phone Number: 01047808321; Email: dreinstein70@gmail.com
  • Seoul, South Korea, 06628
    • Recruiting
    • Ewha Womans University
    • Contact: Chul Han; Phone Number: 01033591937; Email: achwow@ewha.ac.kr
  • Seoul, South Korea, 06628
    • Recruiting
    • Gangnam Severance Hospital
    • Contact: Sung Phil Chung; Phone Number: 01047808321; Email: EMSTAR@yuhs.ac
  • Seoul, South Korea, 06628
    • Recruiting
    • Hanyang University
    • Contact: Tae Ho Im; Phone Number: 01047808321; Email: erthim@gmail.com
  • Seoul, South Korea, 06628
    • Recruiting
    • Jeonbuk National University Hospital
    • Contact: Jae Chol Yoon; Phone Number: 01087818720; Email: jcyoon75@jbnu.ac.kr
  • Seoul, South Korea, 06628
    • Recruiting
    • Korea University Ansan Hospital
    • Contact: Sejoong Ahn; Phone Number: 01029460250; Email: sejoongahn@naver.com
  • Seoul, South Korea, 06628
    • Recruiting
    • Korea University Guro Hospital
    • Contact: Sung Hyuk Choi; Phone Number: 01050599090; Email: kuedchoi@korea.ac.kr
  • Seoul, South Korea, 06628
    • Recruiting
    • Kyung Hee University Hospital
    • Contact: Ki Young Jeong; Phone Number: 01098849119; Email: fly10bird@gmail.com
  • Seoul, South Korea, 06628
    • Recruiting
    • Samsung Medical Center
    • Contact: Tae Gun Shin; Phone Number: 01099335806; Email: tackles@naver.com
  • Seoul, South Korea, 06628
    • Recruiting
    • Soonchunhyang University Bucheon Hospital
    • Contact: Hyun Noh; Phone Number: 01047223657; Email: dingii@schmc.ac.kr
  • Seoul, South Korea, 06628
    • Recruiting
    • Yonsei University Wonju College of Medicine
    • Contact: Kyung Chul Cha; Phone Number: 0104780832101052043365; Email: chaemp@yonsei.ac.kr

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	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	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	AUROC and AUPRC by continuous AI-ECG score	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	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	30 Days
AI-ECG acute myocardial infarction (index visit) discrimination performance	AUROC and AUPRC by continuous AI-ECG score	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	30 Days
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	30 Days
Medical resources utilization	Length of stay in ED	30 days
Medical resources utilization	early discharge from ED(within 4 hours)	24 hours
Medical resources utilization	Revisit to ED with same symptoms within 1 week	7 Days
Medical resources utilization	Admission rate	30 days
Medical resources utilization	length of stay in hospital	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.	30 days
Medical resources utilization	Direct medical cost	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 days
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.	7 days
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	7 days
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.	7 Days
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 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	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	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	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	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	Satisfaction score using AI-ECG from 1-10 (1 is lowest, 10 is highest)	7 Days
Satisfaction score of medical personnel	Satisfaction score using AI-ECG from 1-10 (1 is lowest, 10 is highest)	7 Days
AI-ECG occlusive myocardial infarction detection performance	AUROC and AUPRC by continuous AI-ECG score	30 days
AI-ECG occlusive myocardial infarction detection performance	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	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

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

Study record dates

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): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: acute coronary syndrome; artificial intelligence; emergency department; electrocardiogram; chest pain, suspicious myocardial infarction; AI/ML-enabled SaMd
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Disease Attributes; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergencies; Myocardial Infarction; Acute Coronary Syndrome; Chest Pain
• 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