AI ECG to quickly rule out heart attack (ROMIAE 2)
Official title: ROMIAE 2 Trial: Randomized Controlled Trial for Managing Suspicious Acute Myocardial Infarction in ED Using AI-ECG
Run by CHA University · NCT07027891 · Data updated 2026-11-12
This study will test whether using an AI-read ECG can safely and quickly rule out heart attack in people who come to the emergency department with chest pain and suspected myocardial infarction.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 4670 (estimated) |
| Sponsor | CHA University Academic / other |
| Locations | 12 sites (Seoul and 11 other locations) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | December 30, 2027 |
| Study ends | February 28, 2028 |
| Registry record updated | July 28, 2026 |
| Trial ID | NCT07027891 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People who present to participating emergency departments with chest pain and a clinical suspicion of acute myocardial infarction, without an obvious STEMI or other exclusion criteria, are the ideal candidates.
✕Probably not a fit
Patients with an identified STEMI, clear non-cardiac chest pain, traumatic chest pain, recent revisit for the same symptoms, cardiac arrest, transfer already diagnosed with AMI, or pneumothorax are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares an AI-assisted electrocardiogram (AI-ECG) triage protocol with conventional triage for people presenting to the emergency department with chest pain and suspicion of acute myocardial infarction. Eligible participants present with chest pain suspicious for MI, while patients with STEMI, traumatic or clearly non-cardiac chest pain, recent revisit within one week, pneumothorax, cardiac arrest, or transfer already diagnosed with AMI are excluded. Patients randomized to the AI-ECG arm will have ECGs interpreted by an algorithm to guide early rule-out decisions, and the control arm will follow standard clinical protocols and testing. Outcomes focus on safety and efficacy measures for early triage such as missed MI, time to disposition, and resource use.
Why it matters
Potential benefit: If successful, the AI-ECG protocol could safely speed up ruling out heart attack, reduce unnecessary admissions and testing, and shorten emergency department stays.
How similar studies have gone: Early studies using AI-trained ECG algorithms for acute coronary syndrome and MI rule-out have shown promising results but require larger confirmatory trials like ROMIAE 2.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Asan Medical Center
Seoul, South Korea Recruiting -
CHA Bundang Medical Center
Seoul, South Korea Recruiting -
Ewha Womans University
Seoul, South Korea Recruiting -
Gangnam Severance Hospital
Seoul, South Korea Recruiting -
Hanyang University
Seoul, South Korea Recruiting -
Jeonbuk National University Hospital
Seoul, South Korea Recruiting
Show 6 more locations
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Korea University Ansan Hospital
Seoul, South Korea Recruiting -
Korea University Guro Hospital
Seoul, South Korea Recruiting -
Kyung Hee University Hospital
Seoul, South Korea Recruiting -
Samsung Medical Center
Seoul, South Korea Recruiting -
Soonchunhyang University Bucheon Hospital
Seoul, South Korea Recruiting -
Yonsei University Wonju College of Medicine
Seoul, South Korea Recruiting
Study contacts
- Principal investigator: KYUSEOK Kim, MD, PhD — CHA University
- Study coordinator: Kyuseok Kim, MD, PhD
- Email: dreinstein70@gmail.com
- Phone: +821047808321
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.