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

CHA University

Status: Enrolling

Conditions: Myocardial Infarction (MI); Chest Pain Rule Out Myocardial Infarction

Treatments: Device: AI-ECG

Study type: Interventional

Funder types: Other

Identifiers

NCT07027891

RS-2025-02213791 (Other Grant/Funding Number)

ROMIAE II trial

Details and patient eligibility

About

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.

Enrollment: 4,670 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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4,670 participants in 2 patient groups

Control group

No Intervention group

Description:

The patients in control group would be managed with usual care using HEART score in addition to recent acute coronary syndrome guideline.

AI-ECG group

Experimental group

Description:

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.

Treatment:

Device: AI-ECG