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NCT Number: NCT07027891

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

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.

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Key information

Conditions

Myocardial Infarction (MI) Acute Coronary Syndrome Cardiovascular Diseases Chest Pain Chest Pain Rule Out Myocardial Infarction Disease Attributes Emergencies Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center, Seoul, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AI-ECG

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Missed acute myocardial infarction at index visit

    Time frame: 30 days

    Missed acute myocardial infarction at index ED visit, but is detected later in anyplace (Outpatient clinic, revisit to ED, or other hospital, etc)

  2. AI-ECG 30 days MACE prediction performance

    Time frame: 30 days

    AUROC and AUPRC by continuous AI-ECG score

  3. AI-ECG 30 days MACE prediction performance

    Time frame: 30 Days

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

  4. AI-ECG 30 days MACE prediction performance

    Time frame: 30 Days

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

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

    Time frame: 30 days

    AUROC and AUPRC by continuous AI-ECG score

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

    Time frame: 30 Days

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

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

    Time frame: 30 Days

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

  8. Medical resources utilization

    Time frame: 30 days

    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).

  9. Medical resources utilization

    Time frame: 24 hours

    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).

  10. Medical resources utilization

    Time frame: 7 Days

    Revisit to ED with same symptoms within 1 week

  11. Medical resources utilization

    Time frame: 30 days

    Admission rate will be assessed both in total and according to the risk stratification by HEART score and by study period (Q1-Q4).

  12. Medical resources utilization

    Time frame: 30 days

    length of stay in hospital

  13. Medical resources utilization

    Time frame: 30 days

    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).

  14. Medical resources utilization

    Time frame: 30 days

    Direct medical cost will be assessed both in total and according to the risk stratification by HEART score and by study period (Q1-Q4).

Other outcomes

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

    Time frame: 7 days

    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.

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

    Time frame: 7 days

    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.

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

    Time frame: 7 days

    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

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

    Time frame: 7 Days

    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.

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

    Time frame: 7 Days

    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.

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

    Time frame: 7 Days

    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).

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

    Time frame: 7 Days

    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.

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

    Time frame: 7 Days

    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.

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

    Time frame: 7 Days

    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.

  10. Satisfaction score of patients

    Time frame: 7 Days

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

  11. Satisfaction score of medical personnel

    Time frame: 7 Days

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

  12. AI-ECG occlusive myocardial infarction detection performance

    Time frame: 30 days

    AUROC and AUPRC by continuous AI-ECG score

  13. AI-ECG occlusive myocardial infarction detection performance

    Time frame: 30 days

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

  14. AI-ECG occlusive myocardial infarction detection performance

    Time frame: 30 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Kyuseok Kim, MD, PhD

CONTACT

[email protected]

+821047808321

Sponsors and collaborators

Lead sponsor

CHA University

Other

Registry information

Official study title

ROMIAE 2 Trial: Randomized Controlled Trial for Managing Suspicious Acute Myocardial Infarction in ED Using AI-ECG

Acronym: ROMIAE 2

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jun 19, 2025
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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