Myocardial Infarction (MI)ROMIAE 2NCT07027891
The Rule-Out Acute Myocardial Infarction Using Aritifical Intelligence Electrocardiogram (ROMIAE) 2 Trial
A study testing AI-ECG in people with Myocardial Infarction (MI) and Chest Pain Rule Out Myocardial Infarction, run by CHA University at 12 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction (MI), Chest Pain Rule Out Myocardial Infarction
- What is being tested?
- AI-ECG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,670 participants
- Where
- 12 sitesSouth Korea
- Study dates
- 1 Jul 2025to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chest pain
- suspicious of acute myocardial infarction
Who cannot join
- 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 locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
South Korea12 sites, 12 recruiting
- Recruiting
Asan Medical Center
Seoul, 06628
Won Young Kim, 01072715938, wonpia73@naver.com
- Recruiting
CHA Bundang Medical Center
Seoul, 06628
Kyuseok Kim, 01047808321, dreinstein70@gmail.com
- Recruiting
Ewha Womans University
Seoul, 06628
Chul Han, 01033591937, achwow@ewha.ac.kr
- Recruiting
Gangnam Severance Hospital
Seoul, 06628
Sung Phil Chung, 01047808321, EMSTAR@yuhs.ac
- Recruiting
Hanyang University
Seoul, 06628
Tae Ho Im, 01047808321, erthim@gmail.com
- Recruiting
Jeonbuk National University Hospital
Seoul, 06628
Jae Chol Yoon, 01087818720, jcyoon75@jbnu.ac.kr
- Recruiting
Korea University Ansan Hospital
Seoul, 06628
Sejoong Ahn, 01029460250, sejoongahn@naver.com
- Recruiting
Korea University Guro Hospital
Seoul, 06628
Sung Hyuk Choi, 01050599090, kuedchoi@korea.ac.kr
- Recruiting
Kyung Hee University Hospital
Seoul, 06628
Ki Young Jeong, 01098849119, fly10bird@gmail.com
- Recruiting
Samsung Medical Center
Seoul, 06628
Tae Gun Shin, 01099335806, tackles@naver.com
- Recruiting
Soonchunhyang University Bucheon Hospital
Seoul, 06628
Hyun Noh, 01047223657, dingii@schmc.ac.kr
- Recruiting
Yonsei University Wonju College of Medicine
Seoul, 06628
Kyung Chul Cha, 0104780832101052043365, chaemp@yonsei.ac.kr
About this study
Official title: ROMIAE 2 Trial: Randomized Controlled Trial for Managing Suspicious Acute Myocardial Infarction in ED Using AI-ECG
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.
- Being tested
- AI-ECG
- Keywords
- chest pain, suspicious myocardial infarction, artificial intelligence, electrocardiogram, emergency department, acute coronary syndrome, AI/ML-enabled SaMd
- Medical subject headings
- Myocardial Infarction, Chest Pain, Emergencies, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-ECGDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 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 | 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. Receives: Device: AI-ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 Days MACE(Major adverse cardiac events)
Death, acute myocardial infarction, stroke, target vessel revascularization, stent thrombosis within 30 days from index visit
Measured: 30 days
Secondary outcomes (14)
Missed acute myocardial infarction at index visit
Missed acute myocardial infarction at index ED visit, but is detected later in anyplace (Outpatient clinic, revisit to ED, or other hospital, etc)
Measured: 30 days
AI-ECG 30 days MACE prediction performance
AUROC and AUPRC by continuous AI-ECG score
Measured: 30 days
AI-ECG 30 days MACE prediction performance
Sensitivity and specificity by pre-specified cutoff thresholds for Low to intermediate risk or intermediate to high risk
Measured: 30 Days
AI-ECG 30 days MACE prediction performance
Positive predictive value and Negative predictive value by pre-specified cutoff thresholds for Low to intermediate risk or intermediate to high risk
Measured: 30 Days
AI-ECG acute myocardial infarction (index visit) discrimination performance
AUROC and AUPRC by continuous AI-ECG score
Measured: 30 days
AI-ECG acute myocardial infarction (index visit) discrimination performance
Sensitivity and Specificity by pre-specified cutoff thresholds for Low to intermediate risk or intermediate to high risk
Measured: 30 Days
AI-ECG acute myocardial infarction (index visit) discrimination performance
Positive predictive value and Negative predictive value by pre-specified cutoff thresholds for Low to intermediate risk or intermediate to high risk
Measured: 30 Days
Medical resources utilization
Length of stay in ED will be assessed both in total and according to the risk stratification by HEART score and by study period (Q1-Q4).
Measured: 30 days
Medical resources utilization
Early discharge from ED(within 4 hours) will be assessed both in total and according to the risk stratification by HEART score and by study period (Q1-Q4).
Measured: 24 hours
Medical resources utilization
Revisit to ED with same symptoms within 1 week
Measured: 7 Days
Medical resources utilization
Admission rate will be assessed both in total and according to the risk stratification by HEART score and by study period (Q1-Q4).
Measured: 30 days
Medical resources utilization
length of stay in hospital
Measured: 30 days
Medical resources utilization
It would be evaluated by the rate of all additional tests including cardiac CT, coronary angiography, echocardiography, and stress test. These will be assessed both in total and according to the risk stratification by HEART score and by study period (Q1-Q4).
Measured: 30 days
Medical resources utilization
Direct medical cost will be assessed both in total and according to the risk stratification by HEART score and by study period (Q1-Q4).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start1 Jul 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction (MI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,670 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyuseok Kim, CHA University
- Investigators
- KYUSEOK Kim, MD, PhD, Principal investigator, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027891
- Sponsor's protocol ID
- ROMIAE II trial
- Other IDs
- RS-2025-02213791
- Acronym
- ROMIAE 2
- Status last verified
- Jul 2026
- First submitted
- 27 May 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data would be shared with other researchers when they contact to the principal investigator with reasonable context.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROMIAE 2 Trial: Randomized Controlled Trial for Managing Suspicious Acute Myocardial Infarction in ED Using AI-ECG
- ClinicalTrials.gov ID
- NCT07027891
- Acronym / sponsor ID
- ROMIAE 2 / ROMIAE II trial
- Keywords
- chest pain, suspicious myocardial infarction, artificial intelligence, electrocardiogram, emergency department, acute coronary syndrome, AI/ML-enabled SaMd
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,670 participants (estimated)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –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 | Device: AI-ECGThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chest pain
- suspicious of acute myocardial infarction
Key exclusion criteria (8 listed)
- STEMI
- Revisit of same symptoms within 1 week
- traumatic chest pain
- Pneumothorax
- Transferred from other hospital diagnosed of AMI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-ECGThe 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. | Device | AI-ECG group |
Primary outcome
30 Days MACE(Major adverse cardiac events)
Time frame: 30 days
Death, acute myocardial infarction, stroke, target vessel revascularization, stent thrombosis within 30 days from index visit
14 secondary outcomes
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
Medical resources utilization
Time frame: 30 days
Medical resources utilization
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Yes. The data would be shared with other researchers when they contact to the principal investigator with reasonable context.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
KYUSEOK Kim, MD, PhD principal investigator
CHA University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-ECG in people with Myocardial Infarction (MI) and Chest Pain Rule Out Myocardial Infarction, run by CHA University at 12 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyuseok Kim, MD, PhD (+821047808321, dreinstein70@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 Days MACE(Major adverse cardiac events) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.