Myocardial Infarction or Chest PainROMIAENCT05435391
ROMIAE (Rule-Out Acute Myocardial Infarction Using Artificial Intelligence Electrocardiogram Analysis) Trial
An observational study of Myocardial Infarction or Chest Pain, run by CHA University at 1 site in South Korea.
Trial summary
This study is a prospective multicenter observational study for external validation and model advancement of a deep learning based 12-lead electrocardiogram analysis algorithm targeting adult patients presenting to the emergency department with chest pain and acute myocardial infarction equivalent symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction or Chest Pain
- How many people
- 8,814 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Mar 2022to May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: A total of 20 emergency departments in the Republic of Korea will participate in this study. These centers receive about 800,000 patients annually, and all of these hospitals are capable of their own emergency cardiovascular angiography and percutaneous coronary intervention.
Who may be able to join
- Adults over 18 years of age with suspected chest pain and acute myocardial infarction
- The onset or worsening of the symptom occurs within 24 hours
Who cannot join
- Out-of-hospital cardiac arrest (OHCA): patients with sustained (>20 minutes) return-of-spontaneous-circulation are not excluded
- Patients in whom acute myocardial infarction can be clearly excluded, such as pneumothorax and traumatic chest pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicenter, Observational Diagnostic Study to Externally Validate an Artificial Intelligence 12-lead Electrocardiogram Analysis Algorithm to Detect Patients With Acute Myocardial Infarction Who Visit Emergency Medical Center
This study is a prospective multicenter observational study for external validation and model advancement of a deep learning based 12-lead electrocardiogram analysis algorithm targeting adult patients presenting to the emergency department with chest pain and acute myocardial infarction equivalent symptoms.
About 9,000 adult patients will be enrolled at 20 emergency medical centers in Korea. Artificial intelligence algorithms are manufactured by Medical AI Co., Ltd. It is an advanced version based on the model developed and published in 2020. It had the diagnostic performance of area under the receiver operating curve 0.901 and 0.951 for acute myocardial infarction and ST-segment elevation myocardial infarction, respectively. The primary endpoint is a diagnosis of acute myocardial infarction on the day of the emergency center visit, and the secondary endpoint is a 30-day major adverse cardiac event. From March 2022, patient registration will begin at centers that have been approved by the Institutional Review Board.
This is the first prospective multicenter emergency department validation study for a 12-lead electrocardiogram artificial intelligence algorithm to diagnose acute myocardial infarction. This study will give insight into the direction of future development by verifying whether the deep learning algorithm works well for patients visiting the real-world adult emergency medical center.
- Conditions
- Myocardial Infarction or Chest Pain
- Keywords
- Deep Learning
- Medical subject headings
- Myocardial Infarction, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with chest pain or who are clinically suspected as acute myocardial infarction with equivalent symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of acute myocardial infarction (Type 1, 2)
Accuracy metrics include area under the receiver operating characteristics curve, sensitivity, specificity, positive predictive value, and negative predictive value, along with a 95% confidence interval.
Measured: Index admission
Secondary outcomes (1)
Major adverse cardiovascular event (MACE)
MACE is defined as death, myocardial infarction, stroke, target-vessel revascularization, or stent thrombosis occurring within 30 days of index visit. Accuracy metrics include area under the receiver operating characteristics curve, sensitivity, specificity, positive predictive value, and negative predictive value, along with a 95% confidence interval.
Measured: 30-day after index admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start16 Mar 2022
- Primary completionMar 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial Infarction or Chest PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,814 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical AI Co., Ltd
- Responsible party
- Sponsor
- Investigators
- KS Kim, MD, PhD, Principal investigator, CHA University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435391
- Sponsor's protocol ID
- MAI-CRP-B0000
- Acronym
- ROMIAE
- Status last verified
- Apr 2022
- First submitted
- 13 Jun 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee HS, Kang S, Kwon JM, Shin TG, Lee Y, Kim DH, Choi SH, Cho H, Lee MJ, Jeong KY, Kim WY, Min YG, Han C, Yoon JC, Jung E, Kim WJ, Ahn C, Seo JY, Lim TH, Kim JS, Son JM, Kim KS, Kim K, Lee MS; ROMIAE Study Group. Sex-Consistent Performance of an AI-Enabled ECG for Acute Myocardial Infarction: The ROMIAE Study. JACC Adv. 2026 Jun;5(6 Pt 1):102813. doi: 10.1016/j.jacadv.2026.102813.
PubMed 42312765Shin TG, Lee Y, Kim K, Lee MS, Kwon JM; ROMIAE study group. ROMIAE (Rule-Out Acute Myocardial Infarction Using Artificial Intelligence Electrocardiogram Analysis) trial study protocol: a prospective multicenter observational study for validation of a deep learning-based 12-lead electrocardiogram analysis model for detecting acute myocardial infarction in patients visiting the emergency department. Clin Exp Emerg Med. 2023 Dec;10(4):438-445. doi: 10.15441/ceem.22.360. Epub 2023 Nov 28.
PubMed 38012820
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Observational Diagnostic Study to Externally Validate an Artificial Intelligence 12-lead Electrocardiogram Analysis Algorithm to Detect Patients With Acute Myocardial Infarction Who Visit Emergency Medical Center
- ClinicalTrials.gov ID
- NCT05435391
- Acronym / sponsor ID
- ROMIAE / MAI-CRP-B0000
- Conditions
- Myocardial Infarction or Chest Pain
- Keywords
- Deep Learning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,814 participants (estimated)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Collaborators
- Medical AI Co., Ltd
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 28 Jun 2022 (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 a prospective multicenter observational study for external validation and model advancement of a deep learning based 12-lead electrocardiogram analysis algorithm targeting adult patients presenting to the emergency department with chest pain and acute myocardial infarction equivalent symptoms.
About 9,000 adult patients will be enrolled at 20 emergency medical centers in Korea. Artificial intelligence algorithms are manufactured by Medical AI Co., Ltd. It is an advanced version based on the model developed and published in 2020. It had the diagnostic performance of area under the receiver operating curve 0.901 and 0.951 for acute myocardial infarction and ST-segment elevation myocardial infarction, respectively. The primary endpoint is a diagnosis of acute myocardial infarction on the day of the emergency center visit, and the secondary endpoint is a 30-day major adverse cardiac event. From March 2022, patient registration will begin at centers that have been approved by the Institutional Review Board.
This is the first prospective multicenter emergency department validation study for a 12-lead electrocardiogram artificial intelligence algorithm to diagnose acute myocardial infarction. This study will give insight into the direction of future development by verifying whether the deep learning algorithm works well for patients visiting the real-world adult emergency medical center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Patients with chest pain or who are clinically suspected as acute myocardial infarction with equivalent symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 20 emergency departments in the Republic of Korea will participate in this study. These centers receive about 800,000 patients annually, and all of these hospitals are capable of their own emergency cardiovascular angiography and percutaneous coronary intervention.
Key inclusion criteria (2 listed)
- Adults over 18 years of age with suspected chest pain and acute myocardial infarction
- The onset or worsening of the symptom occurs within 24 hours
Key exclusion criteria (2 listed)
- Out-of-hospital cardiac arrest (OHCA): patients with sustained (>20 minutes) return-of-spontaneous-circulation are not excluded
- Patients in whom acute myocardial infarction can be clearly excluded, such as pneumothorax and traumatic chest pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis of acute myocardial infarction (Type 1, 2)
Time frame: Index admission
Accuracy metrics include area under the receiver operating characteristics curve, sensitivity, specificity, positive predictive value, and negative predictive value, along with a 95% confidence interval.
1 secondary outcome
Major adverse cardiovascular event (MACE)
Time frame: 30-day after index admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Derived from this study: PubMed 42312765Lee HS, Kang S, Kwon JM, Shin TG, Lee Y, Kim DH, Choi SH, Cho H, Lee MJ, Jeong KY, Kim WY, Min YG, Han C, Yoon JC, Jung E, Kim WJ, Ahn C, Seo JY, Lim TH, Kim JS, Son JM, Kim KS, Kim K, Lee MS; ROMIAE Study Group. Sex-Consistent Performance of an AI-Enabled ECG for Acute Myocardial Infarction: The ROMIAE Study. JACC Adv. 2026 Jun;5(6 Pt 1):102813. doi: 10.1016/j.jacadv.2026.102813.
- Derived from this study: PubMed 38012820Shin TG, Lee Y, Kim K, Lee MS, Kwon JM; ROMIAE study group. ROMIAE (Rule-Out Acute Myocardial Infarction Using Artificial Intelligence Electrocardiogram Analysis) trial study protocol: a prospective multicenter observational study for validation of a deep learning-based 12-lead electrocardiogram analysis model for detecting acute myocardial infarction in patients visiting the emergency department. Clin Exp Emerg Med. 2023 Dec;10(4):438-445. doi: 10.15441/ceem.22.360. Epub 2023 Nov 28.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
KS Kim, MD, PhD principal investigator
CHA University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction or Chest Pain, run by CHA University at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of acute myocardial infarction (Type 1, 2) (time frame: Index admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05435391, which also lists 2 linked publications.
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 Jun 2022.