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โ† Trials
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AI-Based Prediction of Atrial Fibrillation in ESUS Patients With ICM

Recruitingn/aAges 30 Years - anyAllInha University Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

5 sites
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
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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