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

NCT ID: NCT07027891

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

4670 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2028-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Infarction (MI) Chest Pain Rule Out Myocardial Infarction

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

AI-ECG group

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.

Group Type EXPERIMENTAL

AI-ECG

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHA University

OTHER

Sponsor Role lead

Responsible Party

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Kyuseok Kim

Professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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KYUSEOK Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHA University

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

CHA Bundang Medical Center

Seoul, , South Korea

Site Status RECRUITING

Ewha Womans University

Seoul, , South Korea

Site Status RECRUITING

Gangnam Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Hanyang University

Seoul, , South Korea

Site Status RECRUITING

Jeonbuk National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Korea University Ansan Hospital

Seoul, , South Korea

Site Status RECRUITING

Korea University Guro Hospital

Seoul, , South Korea

Site Status RECRUITING

Kyung Hee University Hospital

Seoul, , South Korea

Site Status RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Soonchunhyang University Bucheon Hospital

Seoul, , South Korea

Site Status RECRUITING

Yonsei University Wonju College of Medicine

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Kyuseok Kim, MD, PhD

Role: CONTACT

Phone: +821047808321

Email: [email protected]

Facility Contacts

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Won Young Kim

Role: primary

Kyuseok Kim

Role: primary

Chul Han

Role: primary

Sung Phil Chung

Role: primary

Tae Ho Im

Role: primary

Jae Chol Yoon

Role: primary

Sejoong Ahn

Role: primary

Sung Hyuk Choi

Role: primary

Ki Young Jeong

Role: primary

Tae Gun Shin

Role: primary

Hyun Noh

Role: primary

Kyung Chul Cha

Role: primary

Other Identifiers

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RS-2025-02213791

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ROMIAE II trial

Identifier Type: -

Identifier Source: org_study_id