AI-Based Prediction of Atrial Fibrillation in ESUS Patients With ICM

NCT07347691 | Recruiting

• 1 other identifier: 2024-07-024
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 5

Brief Summary

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

Embolic Stroke of Undetermined Source

Keywords

Implantable Cardiac Monitor; Artificial Intelligence; Deep Learning; Electrocardiography; Risk Prediction; Cryptogenic Stroke

Outcome Measures

Primary Outcomes (1)

• Incidence of Atrial Fibrillation (Time-to-Event)

  Comparison of the cumulative incidence rate of atrial fibrillation (AF) events between the High Risk group and the Low to Intermediate Risk group (classified by SmartECG-AF). AF occurrence is confirmed by reviewing data recorded on the Implantable Cardiac Monitor (ICM).

  Up to 12 months

Secondary Outcomes (1)

• Incidence of Major Adverse Cardiovascular Events (MACE)

  Up to 12 months

Study Arms (2)

High Risk Group

Patients classified as having a high risk of atrial fibrillation by the SmartECG-AF AI algorithm.

Low to Intermediate Risk Group

Patients classified as having a low to intermediate risk of atrial fibrillation by the SmartECG-AF AI algorithm.

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Embolic Stroke of Undetermined Source (ESUS) aged 30 years or older who have received or are scheduled to receive an Implantable Cardiac Monitor (ICM). Participants are recruited from five tertiary referral hospitals in South Korea (Inha University Hospital, Jeju National University Hospital, Korea University Guro Hospital, Korea University Ansan Hospital, and Ajou University Hospital).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inha University Hospital: lead
• DeepCardio Co., Ltd.: collaborator

Study Sites (5)

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

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yong-Soo Baek, MD, PhD

  Inha University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong-Soo Baek, MD, PhD

CONTACT

+82-32-890-2200; existsoo@inha.ac.kr

Hyoung Seok Lee, MD

CONTACT

+82-32-890-3575; hyoungseok_lee@inha.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 16, 2026
• Study Start: November 19, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)