AI ECG to quickly rule out heart attack (ROMIAE 2)
ROMIAE 2 Trial: Randomized Controlled Trial for Managing Suspicious Acute Myocardial Infarction in ED Using AI-ECG
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 4670 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CHA University Academic / other |
| Locations | 12 sites (Seoul and 11 other locations) |
| Trial ID | NCT07027891 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Seoul and 11 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.