Actively Recruiting
AI-Based Prediction of Atrial Fibrillation in ESUS Patients With ICM
Led by Inha University Hospital · Updated on 2026-01-16
92
Participants Needed
5
Research Sites
127 weeks
Total Duration
On this page
Sponsors
I
Inha University Hospital
Lead Sponsor
D
DeepCardio Co., Ltd.
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
AI-Based Prediction of Atrial Fibrillation in ESUS Patients With ICM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 30 years or older
- Diagnosed with Embolic Stroke of Undetermined Source (ESUS)
- Have undergone or are scheduled for Implantable Cardiac Monitor (ICM) implantation
- Had at least one 12-lead ECG within 2 weeks before or after ICM implantation
- Sinus Rhythm on ECG at enrollment
- Voluntarily signed informed consent form
You will not qualify if you...
- History of Atrial Fibrillation (AF) before enrollment
- ICM battery at Elective Replacement Interval (ERI) preventing recordings
- ECGs that cannot be analyzed by AI due to severe artifacts, noise, or incompatibility with digital analysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Korea University Ansan Hospital
Ansan, South Korea
Actively Recruiting
2
Inha University Hospital
Incheon, South Korea
Actively Recruiting
3
Jeju National University Hospital
Jeju City, South Korea
Actively Recruiting
4
Korea University Guro Hospital
Seoul, South Korea
Actively Recruiting
5
Ajou University Hospital
Suwon, South Korea
Actively Recruiting
Research Team
Y
Yong-Soo Baek, MD, PhD
CONTACT
H
Hyoung Seok Lee, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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