Acute Myocardial Infarction (AMI)NCT07751809
AI-ECG for Predicting CMR-Defined Myocardial Injury in Acute Myocardial Infarction
An observational study of Acute Myocardial Infarction (AMI), run by Yonsei University at 1 site in South Korea.
Trial summary
This retrospective, single-center external validation study evaluates whether two commercially approved artificial intelligence-enhanced electrocardiography (AI-ECG) algorithms (AiTiA LVSD and AiTiA MI; Medical AI Co., Ltd.), applied to a single pre-percutaneous coronary intervention (PCI) 12-lead ECG, predict cardiac… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Myocardial Infarction (AMI)
- How many people
- 461 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2020to 30 Jun 2025
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive AMI patients undergoing PCI and post-PCI CMR, both algorithms were applied to the pre-PCI ECG
Who may be able to join
- Acute myocardial infarction (STEMI or NSTEMI) undergoing PCI
- Subsequent cardiac magnetic resonance imaging performed
- Valid pre-PCI 12-lead ECG processable by both AI-ECG algorithms
Who cannot join
- Duplicate AMI enrollment
- Invalid ECG-CMR date linkage
- No valid pre-PCI 12-lead ECG processable by both algorithms
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yongin Severance Hospital, Yonsei University College of Medicine
Yongin-si, Gyeonggi-do, 16995
About this study
Official title: Artificial Intelligence-Enhanced ECG for Predicting Cardiac Magnetic Resonance-Defined Myocardial Injury in Acute Myocardial Infarction: An External Validation Study
This retrospective, single-center external validation study evaluates whether two commercially approved artificial intelligence-enhanced electrocardiography (AI-ECG) algorithms (AiTiA LVSD and AiTiA MI; Medical AI Co., Ltd.), applied to a single pre-percutaneous coronary intervention (PCI) 12-lead ECG, predict cardiac magnetic resonance (CMR)-defined myocardial injury in patients with acute myocardial infarction (AMI). The primary endpoint is a large infarct (late gadolinium enhancement >17.9% of left ventricular mass); secondary endpoints are CMR left ventricular ejection fraction (LVEF) ≤40% and microvascular obstruction (MVO).
Read the detailed description
Consecutive patients with acute myocardial infarction undergoing PCI and subsequent CMR at Yongin Severance Hospital (April 2020-June 2025) were identified. Two approved AI-ECG algorithms were applied to the first 12-lead ECG obtained at emergency-department presentation (pre-PCI). CMR was performed a median of 3 days (IQR 2-5) after PCI. The diagnostic performance of each AI-ECG score for the CMR-defined endpoints was assessed by the area under the ROC curve (AUC), with sensitivity, specificity, and predictive values at prespecified and cohort-optimal (Youden) cutoffs, and by logistic regression. The final analysis cohort comprised 461 patients.
- Conditions
- Acute Myocardial Infarction (AMI)
- Keywords
- Artificial Intelligence, Electrocardiography, cardiac magnetic resonance, Acute Myocardial Infarction
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 |
|---|---|---|
| Consecutive AMI patients (STEMI or NSTEMI) undergoing PCI with a valid pre-PCI 12-lead ECG processab | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Large myocardial infarct on CMR
: Late gadolinium enhancement (LGE) >17.9% of left ventricular mass, assessed on CMR. Discrimination of the pre-PCI AI-ECG score reported as AUC.
Measured: CMR performed a median of 3 days (IQR 2-5) after PCI, during the index hospitalization.
Secondary outcomes (2)
CMR-defined LV systolic dysfunction
CMR-derived left ventricular ejection fraction (LVEF) ≤40%.
Measured: CMR performed a median of 3 days (IQR 2-5) after PCI.
Microvascular obstruction (MVO)
Presence of microvascular obstruction on CMR.
Measured: CMR performed a median of 3 days (IQR 2-5) after PCI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Apr 2020
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction (AMI)Studies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical AI
- Responsible party
- Principal investigator, Yongcheol Kim, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751809
- Sponsor's protocol ID
- 9-2025-0106
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be made available. The study analyzed retrospectively collected, de-identified data under an IRB-approved protocol with a consent waiver; the governing data-use terms do not permit sharing of individual participant data. Aggregate results are reported in the associated publication, and reasonable inquiries may be directed to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-Enhanced ECG for Predicting Cardiac Magnetic Resonance-Defined Myocardial Injury in Acute Myocardial Infarction: An External Validation Study
- ClinicalTrials.gov ID
- NCT07751809
- Acronym / sponsor ID
- 9-2025-0106
- Conditions
- Acute Myocardial Infarction (AMI)
- Keywords
- Artificial Intelligence, Electrocardiography, cardiac magnetic resonance, Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Medical AI
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 7 Aug 2026 (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 retrospective, single-center external validation study evaluates whether two commercially approved artificial intelligence-enhanced electrocardiography (AI-ECG) algorithms (AiTiA LVSD and AiTiA MI; Medical AI Co., Ltd.), applied to a single pre-percutaneous coronary intervention (PCI) 12-lead ECG, predict cardiac magnetic resonance (CMR)-defined myocardial injury in patients with acute myocardial infarction (AMI). The primary endpoint is a large infarct (late gadolinium enhancement >17.9% of left ventricular mass); secondary endpoints are CMR left ventricular ejection fraction (LVEF) ≤40% and microvascular obstruction (MVO).
Detailed description
Consecutive patients with acute myocardial infarction undergoing PCI and subsequent CMR at Yongin Severance Hospital (April 2020-June 2025) were identified. Two approved AI-ECG algorithms were applied to the first 12-lead ECG obtained at emergency-department presentation (pre-PCI). CMR was performed a median of 3 days (IQR 2-5) after PCI. The diagnostic performance of each AI-ECG score for the CMR-defined endpoints was assessed by the area under the ROC curve (AUC), with sensitivity, specificity, and predictive values at prespecified and cohort-optimal (Youden) cutoffs, and by logistic regression. The final analysis cohort comprised 461 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consecutive AMI patients (STEMI or NSTEMI) undergoing PCI with a valid pre-PCI 12-lead ECG processab | – | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive AMI patients undergoing PCI and post-PCI CMR, both algorithms were applied to the pre-PCI ECG
Key inclusion criteria (3 listed)
- Acute myocardial infarction (STEMI or NSTEMI) undergoing PCI
- Subsequent cardiac magnetic resonance imaging performed
- Valid pre-PCI 12-lead ECG processable by both AI-ECG algorithms
Key exclusion criteria (3 listed)
- Duplicate AMI enrollment
- Invalid ECG-CMR date linkage
- No valid pre-PCI 12-lead ECG processable by both algorithms
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
Large myocardial infarct on CMR
Time frame: CMR performed a median of 3 days (IQR 2-5) after PCI, during the index hospitalization.
: Late gadolinium enhancement (LGE) >17.9% of left ventricular mass, assessed on CMR. Discrimination of the pre-PCI AI-ECG score reported as AUC.
2 secondary outcomes
CMR-defined LV systolic dysfunction
Time frame: CMR performed a median of 3 days (IQR 2-5) after PCI.
Microvascular obstruction (MVO)
Time frame: CMR performed a median of 3 days (IQR 2-5) after PCI.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made available. The study analyzed retrospectively collected, de-identified data under an IRB-approved protocol with a consent waiver; the governing data-use terms do not permit sharing of individual participant data. Aggregate results are reported in the associated publication, and reasonable inquiries may be directed to the principal investigator.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Myocardial Infarction (AMI), run by Yonsei 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 7 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Large myocardial infarct on CMR (time frame: CMR performed a median of 3 days (IQR 2-5) after PCI, during the index hospitalization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2026.