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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07027891

Acronym

ROMIAE 2

Enrollment

4670

Registered

2025-06-19

Start date

2025-07-01

Completion date

2028-02-28

Last updated

2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest Pain Rule Out Myocardial Infarction, Myocardial Infarction (MI)

Keywords

chest pain, suspicious myocardial infarction, artificial intelligence, electrocardiogram, emergency department, acute coronary syndrome, AI/ML-enabled SaMd

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.

Interventions

DEVICEAI-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	AUROC and AUPRC by continuous AI-ECG score
AI-ECG acute myocardial infarction (index visit) discrimination performance	30 days	AUROC and AUPRC by continuous AI-ECG score
Medical resources utilization	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).

Countries

South Korea

Contacts

CONTACTKyuseok Kim, MD, PhD

dreinstein70@gmail.com+821047808321

PRINCIPAL_INVESTIGATORKYUSEOK Kim, MD, PhD

CHA University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026