AI analysis of ECGs to predict atrial fibrillation risk in ESUS patients with an implantable cardiac monitor.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter prospective observational study applies the SmartECG-AF deep learning algorithm to baseline 12-lead ECGs from patients with Embolic Stroke of Undetermined Source who have an implantable cardiac monitor (ICM). Patients will be classified by the AI score into a High Risk group and a Low-to-Intermediate Risk control group and then followed longitudinally using ICM recordings. The primary analysis compares time-to-first ICM-detected atrial fibrillation event between risk groups, and secondary analyses examine the relationship between AI-predicted risk and major adverse cardiovascular events (MACE). The study aims to validate whether AI-guided ECG risk stratification can identify occult AF and inform post-ESUS monitoring strategies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Korea University Ansan Hospital
  Ansan, South Korea Recruiting
• Inha University Hospital
  Incheon, South Korea Recruiting
• Jeju National University Hospital
  Jeju City, South Korea Recruiting
• Korea University Guro Hospital
  Seoul, South Korea Recruiting
• Ajou University Hospital
  Suwon, South Korea Recruiting

Study contacts

• Principal investigator: Yong-Soo Baek, MD, PhD — Inha University Hospital
• Study coordinator: Yong-Soo Baek, MD, PhD
• Email: existsoo@inha.ac.kr
• Phone: +82-32-890-2200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.