ClinicalTrials.gg
RecruitingNCT07027891ROMIAE 2Updated Jul 28, 2026

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

An interventional study of AI-ECG in Myocardial Infarction (MI) and Chest Pain Rule Out Myocardial Infarction, sponsored by CHA University. Recruiting at 12 sites in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by CHA University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
4,670
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Myocardial Infarction (MI)
  • Chest Pain Rule Out Myocardial Infarction

Keywords

  • chest pain, suspicious myocardial infarction
  • artificial intelligence
  • electrocardiogram
  • emergency department
  • acute coronary syndrome
  • AI/ML-enabled SaMd
03

In context

Myocardial Infarction

2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.

This study's planned enrollment of 4,670 is above the median of 150 across 1,314 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

CHA University is the lead sponsor of 54 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • chest pain
  • suspicious of acute myocardial infarction

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
4,670 participants (estimated)

Study arms

  • No intervention
    Control group

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

  • Experimental
    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.

    Device: AI-ECG

Interventions

  • DeviceAI-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.

06

What researchers measure

Primary outcomes

  1. 30 Days MACE(Major adverse cardiac events)

    Death, acute myocardial infarction, stroke, target vessel revascularization, stent thrombosis within 30 days from index visit

    Time frame: 30 days

Secondary outcomes

  1. 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)

    Time frame: 30 days

  2. AI-ECG 30 days MACE prediction performance

    AUROC and AUPRC by continuous AI-ECG score

    Time frame: 30 days

  3. 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

    Time frame: 30 Days

  4. 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

    Time frame: 30 Days

  5. AI-ECG acute myocardial infarction (index visit) discrimination performance

    AUROC and AUPRC by continuous AI-ECG score

    Time frame: 30 days

  6. 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

    Time frame: 30 Days

  7. 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

    Time frame: 30 Days

  8. 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).

    Time frame: 30 days

  9. 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).

    Time frame: 24 hours

  10. Medical resources utilization

    Revisit to ED with same symptoms within 1 week

    Time frame: 7 Days

  11. 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).

    Time frame: 30 days

  12. Medical resources utilization

    length of stay in hospital

    Time frame: 30 days

  13. 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).

    Time frame: 30 days

  14. 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).

    Time frame: 30 days

Other outcomes

  1. Compliance of medical doctor in AI-ECG low risk group

    Compliance of medical doctors to AI-ECG results in AI-ECG low risk group according to the study period(Q1 to Q4), which would be evaluated by discharge rate from ED.

    Time frame: 7 days

  2. Compliance of medical doctor in AI-ECG low risk group

    Compliance of medical doctors to AI-ECG results in AI-ECG low risk group according to the study period(Q1 to Q4), which would be evaluated by the rate of no follow-up troponin check.

    Time frame: 7 days

  3. Compliance of medical doctor in AI-ECG low risk group

    Compliance of medical doctors to AI-ECG results in AI-ECG low risk group according to the study period(Q1 to Q4), which would be evaluated by the rate of only baseline and 1 h follow-up troponin check

    Time frame: 7 days

  4. Compliance of medical doctor in AI-ECG high risk group

    Compliance of medical doctors to AI-ECG results in AI-ECG high risk group according to the study period(Q1 to Q4), which would be evaluated by admission rate.

    Time frame: 7 Days

  5. Compliance of medical doctor in AI-ECG high risk group

    Compliance of medical doctors to AI-ECG results in AI-ECG high risk group according to the study period(Q1 to Q4), which would be evaluated by the sum rate of additional tests such as coronary artery CT, CAG, stress test.

    Time frame: 7 Days

  6. Compliance of medical doctor in AI-ECG high risk group

    Compliance of medical doctors to AI-ECG results in AI-ECG high risk group according to the study period(Q1 to Q4), which would be evaluated by the rate of full check up of troponin(0, 1h, 2h).

    Time frame: 7 Days

  7. Compliance of medical doctor in AI-ECG high risk group

    Compliance of medical doctors to AI-ECG results in AI-ECG high risk group according to the study period(Q1 to Q4), which would be evaluated by time from ED to admission.

    Time frame: 7 Days

  8. Compliance of medical doctor in AI-ECG high risk group

    Compliance of medical doctors to AI-ECG results in AI-ECG high risk group according to the study period(Q1 to Q4), which would be evaluated by time to CAG.

    Time frame: 7 Days

  9. Compliance of medical doctor in AI-ECG high risk group

    Compliance of medical doctors to AI-ECG results in AI-ECG high risk group according to the study period(Q1 to Q4), which would be evaluated by cardiology contact rate.

    Time frame: 7 Days

  10. Satisfaction score of patients

    Satisfaction score using AI-ECG from 1-10 (1 is lowest, 10 is highest)

    Time frame: 7 Days

  11. Satisfaction score of medical personnel

    Satisfaction score using AI-ECG from 1-10 (1 is lowest, 10 is highest)

    Time frame: 7 Days

  12. AI-ECG occlusive myocardial infarction detection performance

    AUROC and AUPRC by continuous AI-ECG score

    Time frame: 30 days

  13. AI-ECG occlusive myocardial infarction detection performance

    Sensitivity and Specificity by pre-specified cutoff thresholds for Low to intermediate risk or intermediate to high risk

    Time frame: 30 days

  14. AI-ECG occlusive myocardial infarction detection performance

    Positive predictive value and Negative predictive value by pre-specified cutoff thresholds for Low to intermediate risk or intermediate to high risk

    Time frame: 30 days

07

Study locations

12 of 12 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — The data would be shared with other researchers when they contact to the principal investigator with reasonable context.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2025 (actual). Primary completion is estimated for Dec 2027, 29 months after the start.

Of 321 non-industry interventional studies with no phase under Myocardial Infarction, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 58. This study's planned 29 months is below that.

Counting every sponsor, half of 354 studies reached it within 34 months; a quarter within 15 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
May 27, 2025
First posted
Jun 19, 2025
StartActual
Jul 1, 2025
Primary completionEst.
Dec 30, 2027
CompletionEst.
Feb 28, 2028
Last update
Jul 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07027891
Lead sponsor
CHA University
Responsible party
Kyuseok Kim (Professor, MD, PhD, CHA University) — Principal investigator
First posted
Jun 19, 2025
Start date
Jul 1, 2025
Primary completion
Dec 30, 2027 (estimated)
Completion
Feb 28, 2028 (estimated)
Last update
Jul 28, 2026

Study contacts

Kyuseok Kim, MD, PhD
Contact
dreinstein70@gmail.com
+821047808321
KYUSEOK Kim, MD, PhD
principal investigator · CHA University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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