NCT07027891

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,670

participants targeted

Target at P75+ for not_applicable

Timeline
22mo left

Started Jul 2025

Typical duration for not_applicable

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Jul 2025Feb 2028

First Submitted

Initial submission to the registry

May 27, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2028

Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

2.5 years

First QC Date

May 27, 2025

Last Update Submit

December 18, 2025

Conditions

Myocardial Infarction (MI)Chest Pain Rule Out Myocardial Infarction

Keywords

chest pain, suspicious myocardial infarctionartificial intelligenceelectrocardiogramemergency departmentacute coronary syndromeAI/ML-enabled SaMd

Outcome Measures

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

    30 days

Secondary Outcomes (14)

  • Missed acute myocardial infarction at index visit

    30 days

  • AI-ECG 30 days MACE prediction performance

    30 days

  • AI-ECG 30 days MACE prediction performance

    30 Days

  • AI-ECG 30 days MACE prediction performance

    30 Days

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

    30 days

  • +9 more secondary outcomes

Other Outcomes (14)

  • Compliance of medical doctor in AI-ECG low risk group

    7 days

  • Compliance of medical doctor in AI-ECG low risk group

    7 days

  • Compliance of medical doctor in AI-ECG low risk group

    7 days

  • +11 more other outcomes

Study Arms (2)

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.

Device: AI-ECG

Interventions

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.

AI-ECG group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chest pain
  • suspicious of acute myocardial infarction

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Asan Medical Center

Seoul, 06628, South Korea

RECRUITING

CHA Bundang Medical Center

Seoul, 06628, South Korea

RECRUITING

Ewha Womans University

Seoul, 06628, South Korea

RECRUITING

Gangnam Severance Hospital

Seoul, 06628, South Korea

RECRUITING

Hanyang University

Seoul, 06628, South Korea

RECRUITING

Jeonbuk National University Hospital

Seoul, 06628, South Korea

RECRUITING

Korea University Ansan Hospital

Seoul, 06628, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, 06628, South Korea

RECRUITING

Kyung Hee University Hospital

Seoul, 06628, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06628, South Korea

RECRUITING

Soonchunhyang University Bucheon Hospital

Seoul, 06628, South Korea

RECRUITING

Yonsei University Wonju College of Medicine

Seoul, 06628, South Korea

RECRUITING

MeSH Terms

Conditions

Myocardial InfarctionChest PainEmergenciesAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisPainNeurologic ManifestationsSigns and SymptomsDisease Attributes

Study Officials

  • KYUSEOK Kim, MD, PhD

    CHA University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyuseok Kim, MD, PhD

CONTACT

+821047808321dreinstein70@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, PhD

Study Record Dates

First Submitted

May 27, 2025

First Posted

June 19, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

February 28, 2028

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

The data would be shared with other researchers when they contact to the principal investigator with reasonable context.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

KR(12)