AI-Based Prediction of Atrial Fibrillation in ESUS Patients With ICM
Recruiting · NCT07347691 · Observational (researchers observe without assigning treatment) · Lead sponsor: Inha University Hospital
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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 is running
5 locations listed.
- Korea University Ansan Hospital - Ansan, South Korea
- Inha University Hospital - Incheon, South Korea
- Jeju National University Hospital - Jeju City, South Korea
- Korea University Guro Hospital - Seoul, South Korea
- Ajou University Hospital - Suwon, South Korea