ROMIAE (Rule-Out Acute Myocardial Infarction Using Artificial Intelligence Electrocardiogram Analysis) Trial

NCT05435391 | Unknown DMC

• 1 other identifier: MAI-CRP-B0000
• Study Type: observational
• Target: 8,814
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Index admission

Secondary Outcomes (1)

• Major adverse cardiovascular event (MACE)

  30-day after index admission

Other Outcomes (4)

• AI ECG analysis versus clinical risk score (HEART score)

  Index admission, 30-day after index admission

• AI ECG analysis versus clinical risk score (GRACE 2.0 score)

  Index admission, 30-day after index admission

• AI ECG analysis versus cardiac biomarker

  Index admission

Study Arms (1)

Group 1

Patients with chest pain or who are clinically suspected as acute myocardial infarction with equivalent symptoms.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHA University: lead
• Medical AI Co., Ltd: collaborator

Study Sites (1)

CHA Bundang Medical Center

Seongnam, South Korea

Location

Related Publications (1)

• Shin 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.

  PMID: 38012820 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Chest Pain

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• KS Kim, MD, PhD

  CHA University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 28, 2022
• Study Start: March 16, 2022
• Primary Completion: March 1, 2023
• Study Completion: May 1, 2023
• Last Updated: June 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)