Recruiting NCT07027891
The Rule-Out Acute Myocardial Infarction Using Aritifical Intelligence Electrocardiogram (ROMIAE) 2 Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI-ECG.
- Who it may be relevant to
- Registry conditions: Myocardial Infarction (MI), Chest Pain Rule Out Myocardial Infarction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ROMIAE 2 Trial: Randomized Controlled Trial for Managing Suspicious Acute Myocardial Infarction in ED Using AI-ECG
Overview
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
- 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.
Primary outcome measures
- 30 Days MACE(Major adverse cardiac events) [Time frame: 30 days]
Secondary outcome measures (12)
- Missed acute myocardial infarction at index visit [Time frame: 30 days]
- AI-ECG 30 days MACE prediction performance [Time frame: 30 days]
- AI-ECG 30 days MACE prediction performance [Time frame: 30 Days]
- AI-ECG 30 days MACE prediction performance [Time frame: 30 Days]
- AI-ECG acute myocardial infarction (index visit) discrimination performance [Time frame: 30 days]
- AI-ECG acute myocardial infarction (index visit) discrimination performance [Time frame: 30 Days]
- AI-ECG acute myocardial infarction (index visit) discrimination performance [Time frame: 30 Days]
- Medical resources utilization [Time frame: 30 days]
- Medical resources utilization [Time frame: 24 hours]
- Medical resources utilization [Time frame: 7 Days]
- Medical resources utilization [Time frame: 30 days]
- Medical resources utilization [Time frame: 30 days]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
South Korea · 12 centers
- Asan Medical Center — Seoul
- CHA Bundang Medical Center — Seoul
- Ewha Womans University — Seoul
- Gangnam Severance Hospital — Seoul
- Hanyang University — Seoul
- Jeonbuk National University Hospital — Seoul
- Korea University Ansan Hospital — Seoul
- Korea University Guro Hospital — Seoul
- … and 4 more centers
Identifiers
NCT: NCT07027891 · ROMIAE II trial · RS-2025-02213791