Embolic Stroke of Undetermined SourceSMART-ESUSNCT07347691
AI-Based Prediction of Atrial Fibrillation in ESUS Patients With ICM
An observational study of Embolic Stroke of Undetermined Source, run by Inha University Hospital at 5 sites in South Korea.
Trial summary
This study investigates patients with Embolic Stroke of Undetermined Source (ESUS) who have received an Implantable Cardiac Monitor (ICM). The main purpose is to evaluate the predictive value of an Artificial Intelligence ECG analysis tool, named SmartECG-AF. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Embolic Stroke of Undetermined Source
- How many people
- 92 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 19 Nov 2025to May 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with Embolic Stroke of Undetermined Source (ESUS) aged 30 years or older who have received or are scheduled to receive an Implantable Cardiac Monitor (ICM). Participants are recruited from five tertiary referral hospitals in South Korea (Inha University Hospital, Jeju National University Hospital, Korea University Guro Hospital, Korea University Ansan Hospital, and Ajou University Hospital).
Who may be able to join
- Patients aged 30 years or older.
- Patients diagnosed with Embolic Stroke of Undetermined Source (ESUS) who have undergone or are scheduled for Implantable Cardiac Monitor (ICM) implantation.
- Patients who have undergone at least one 12-lead ECG examination within 2 weeks before or after the date of ICM implantation.
- Patients maintaining Sinus Rhythm on ECG at the time of enrollment.
- Patients who have voluntarily signed the informed consent form.
Who cannot join
- Patients diagnosed with Atrial Fibrillation (AF) at least once prior to the date of enrollment.
- Patients whose ICM battery status is at Elective Replacement Interval (ERI), making recording impossible.
- Patients whose ECGs cannot be analyzed by the AI algorithm (SmartECG-AF) due to severe artifacts or noise, or are incompatible with digital analysis.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
South Korea5 sites, 5 recruiting
- Recruiting
Korea University Ansan Hospital
Ansan
Sangmi Oh, +82-31-412-5114, osm221001@gmail.com
Seung-yong Shin, M.D., Ph.D., +82-31-412-5114, theshin04@naver.com
- Recruiting
Inha University Hospital
Incheon
Hyerim Park, +82-32-890-2114, rimvely1126@naver.com
Yong-Soo Baek, MD, PhD, +82-32-890-2200, existsoo@inha.ac.kr
- Recruiting
Jeju National University Hospital
Jeju City
Jin-hee Kim, +82-64-717-6000, wpwndurh77@naver.com
Ki Yung Boo, MD, PhD, +82-64-717-6000, pidori@hanmail.net
- Recruiting
Korea University Guro Hospital
Seoul
Yoonhee Choi, +82-2--2626-2336, grkmcgrca009@kumc.or.kr
Dae-in Lee, MD, PhD, +82-2-2626-1114, acttopia@gmail.com
- Recruiting
Ajou University Hospital
Suwon
Jihee Kang, +82-31-219-4329, haagendasss@gmail.com
Kwang-No Lee, MD, PhD, +82-31-219-7830, knlee81@ajou.ac.kr
About this study
Official title: Predicting Atrial Fibrillation in Patients With Post-implantable Cardiac Monitor Implementation : A Prospective, Long-term Follow-up Study Using Comprehensive AI ECG Analysis : Multicenter Prospective Study
This study investigates patients with Embolic Stroke of Undetermined Source (ESUS) who have received an Implantable Cardiac Monitor (ICM). The main purpose is to evaluate the predictive value of an Artificial Intelligence ECG analysis tool, named SmartECG-AF.
Participants will be classified into two groups based on the AI analysis: a "High Risk" group and a "Low to Intermediate Risk" (control) group. The study aims to compare the incidence rate of atrial fibrillation (AF) events over time between these two groups. Additionally, the study will analyze the relationship between the AI-predicted risk levels and the occurrence of major cardiovascular events during the follow-up period.
Read the detailed description
Embolic Stroke of Undetermined Source (ESUS) accounts for a significant proportion of ischemic strokes, and occult Atrial Fibrillation (AF) is considered a major etiology. While Implantable Cardiac Monitors (ICMs) are the gold standard for long-term rhythm monitoring, identifying patients at the highest risk for AF remains a clinical challenge.
This multicenter, prospective study aims to validate the clinical utility of an artificial intelligence-based electrocardiogram analysis algorithm, "SmartECG-AF," in this specific population. The algorithm analyzes 12-lead ECGs recorded during sinus rhythm to detect subtle signs of electrical remodeling associated with paroxysmal AF.
Enrolled patients with ESUS who have undergone ICM implantation will have their baseline ECGs analyzed by the SmartECG-AF algorithm. Based on the AI-generated probability score, patients will be stratified into a "High Risk" group and a "Low to Intermediate Risk" group. The study will longitudinally track these patients to compare the time-to-event for ICM-detected AF between the two groups. Additionally, the study will evaluate the correlation between the AI risk score and the incidence of Major Adverse Cardiovascular Events (MACE), providing evidence for AI-guided risk stratification in cryptogenic stroke management.
- Conditions
- Embolic Stroke of Undetermined Source
- Keywords
- Implantable Cardiac Monitor, Artificial Intelligence, Deep Learning, Electrocardiography, Risk Prediction, Cryptogenic Stroke
- Medical subject headings
- Ischemic Stroke
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 |
|---|---|---|
| High Risk Group | Patients classified as having a high risk of atrial fibrillation by the SmartECG-AF AI algorithm. | |
| Low to Intermediate Risk Group | Patients classified as having a low to intermediate risk of atrial fibrillation by the SmartECG-AF AI algorithm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Atrial Fibrillation (Time-to-Event)
Comparison of the cumulative incidence rate of atrial fibrillation (AF) events between the High Risk group and the Low to Intermediate Risk group (classified by SmartECG-AF). AF occurrence is confirmed by reviewing data recorded on the Implantable Cardiac Monitor (ICM).
Measured: Up to 12 months
Secondary outcomes (1)
Incidence of Major Adverse Cardiovascular Events (MACE)
Evaluation of the composite rate of major clinical events including recurrent stroke, hospitalization for heart failure, myocardial infarction, and all-cause death (cardiovascular and non-cardiovascular). The study will analyze the correlation between the occurrence of these events and the AI-predicted risk levels.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start19 Nov 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embolic Stroke of Undetermined SourceStudies 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
- 92 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- DeepCardio Co., Ltd.
- Responsible party
- Principal investigator, Yong-Soo Baek, Inha University Hospital
- Investigators
- Yong-Soo Baek, MD, PhD, Principal investigator, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347691
- Sponsor's protocol ID
- 2024-07-024
- Acronym
- SMART-ESUS
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant privacy and confidentiality. The informed consent form signed by participants does not include authorization for the release of individual raw data to third parties.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Atrial Fibrillation in Patients With Post-implantable Cardiac Monitor Implementation : A Prospective, Long-term Follow-up Study Using Comprehensive AI ECG Analysis : Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT07347691
- Acronym / sponsor ID
- SMART-ESUS / 2024-07-024
- Conditions
- Embolic Stroke of Undetermined Source
- Keywords
- Implantable Cardiac Monitor, Artificial Intelligence, Deep Learning, Electrocardiography, Risk Prediction, Cryptogenic Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Collaborators
- DeepCardio Co., Ltd.
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 16 Jan 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 study investigates patients with Embolic Stroke of Undetermined Source (ESUS) who have received an Implantable Cardiac Monitor (ICM). The main purpose is to evaluate the predictive value of an Artificial Intelligence ECG analysis tool, named SmartECG-AF.
Participants will be classified into two groups based on the AI analysis: a "High Risk" group and a "Low to Intermediate Risk" (control) group. The study aims to compare the incidence rate of atrial fibrillation (AF) events over time between these two groups. Additionally, the study will analyze the relationship between the AI-predicted risk levels and the occurrence of major cardiovascular events during the follow-up period.
Detailed description
Embolic Stroke of Undetermined Source (ESUS) accounts for a significant proportion of ischemic strokes, and occult Atrial Fibrillation (AF) is considered a major etiology. While Implantable Cardiac Monitors (ICMs) are the gold standard for long-term rhythm monitoring, identifying patients at the highest risk for AF remains a clinical challenge.
This multicenter, prospective study aims to validate the clinical utility of an artificial intelligence-based electrocardiogram analysis algorithm, "SmartECG-AF," in this specific population. The algorithm analyzes 12-lead ECGs recorded during sinus rhythm to detect subtle signs of electrical remodeling associated with paroxysmal AF.
Enrolled patients with ESUS who have undergone ICM implantation will have their baseline ECGs analyzed by the SmartECG-AF algorithm. Based on the AI-generated probability score, patients will be stratified into a "High Risk" group and a "Low to Intermediate Risk" group. The study will longitudinally track these patients to compare the time-to-event for ICM-detected AF between the two groups. Additionally, the study will evaluate the correlation between the AI risk score and the incidence of Major Adverse Cardiovascular Events (MACE), providing evidence for AI-guided risk stratification in cryptogenic stroke management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Risk Group | – | –Patients classified as having a high risk of atrial fibrillation by the SmartECG-AF AI algorithm. |
| Low to Intermediate Risk Group | – | –Patients classified as having a low to intermediate risk of atrial fibrillation by the SmartECG-AF AI algorithm. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Embolic Stroke of Undetermined Source (ESUS) aged 30 years or older who have received or are scheduled to receive an Implantable Cardiac Monitor (ICM). Participants are recruited from five tertiary referral hospitals in South Korea (Inha University Hospital, Jeju National University Hospital, Korea University Guro Hospital, Korea University Ansan Hospital, and Ajou University Hospital).
Key inclusion criteria (5 listed)
- Patients aged 30 years or older.
- Patients diagnosed with Embolic Stroke of Undetermined Source (ESUS) who have undergone or are scheduled for Implantable Cardiac Monitor (ICM) implantation.
- Patients who have undergone at least one 12-lead ECG examination within 2 weeks before or after the date of ICM implantation.
- Patients maintaining Sinus Rhythm on ECG at the time of enrollment.
- Patients who have voluntarily signed the informed consent form.
Key exclusion criteria (3 listed)
- Patients diagnosed with Atrial Fibrillation (AF) at least once prior to the date of enrollment.
- Patients whose ICM battery status is at Elective Replacement Interval (ERI), making recording impossible.
- Patients whose ECGs cannot be analyzed by the AI algorithm (SmartECG-AF) due to severe artifacts or noise, or are incompatible with digital analysis.
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
Incidence of Atrial Fibrillation (Time-to-Event)
Time frame: Up to 12 months
Comparison of the cumulative incidence rate of atrial fibrillation (AF) events between the High Risk group and the Low to Intermediate Risk group (classified by SmartECG-AF). AF occurrence is confirmed by reviewing data recorded on the Implantable Cardiac Monitor (ICM).
1 secondary outcome
Incidence of Major Adverse Cardiovascular Events (MACE)
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant privacy and confidentiality. The informed consent form signed by participants does not include authorization for the release of individual raw data to third parties.
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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.
Yong-Soo Baek, MD, PhD principal investigator
Inha University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Embolic Stroke of Undetermined Source, run by Inha University Hospital at 5 sites 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 5 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: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong-Soo Baek, MD, PhD (+82-32-890-2200, existsoo@inha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Atrial Fibrillation (Time-to-Event) (time frame: Up to 12 months). 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 16 Jan 2026.