AI-Based Prediction of Atrial Fibrillation in ESUS Patients With ICM
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Embolic Stroke of Undetermined Source. Basic parameters: from 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Primary outcome measures
- Incidence of Atrial Fibrillation (Time-to-Event) [Time frame: Up to 12 months]
Secondary outcome measures (1)
- Incidence of Major Adverse Cardiovascular Events (MACE) [Time frame: Up to 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 5 centers
- Korea University Ansan Hospital — Ansan
- Inha University Hospital — Incheon
- Jeju National University Hospital — Jeju City
- Korea University Guro Hospital — Seoul
- Ajou University Hospital — Suwon
Identifiers
NCT: NCT07347691 · 2024-07-024