Stroke Clinical Trials

Find Stroke Clinical Trials Near You

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

Status: Recruiting
Location: See all (5) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Republic of Korea
Korea University Ansan Hospital
RECRUITING
Ansan
Inha University Hospital
RECRUITING
Incheon
Jeju National University Hospital
RECRUITING
Jeju City
Korea University Guro Hospital
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
Contact Information
Primary
Yong-Soo Baek, MD, PhD
existsoo@inha.ac.kr
+82-32-890-2200
Backup
Hyoung Seok Lee, MD
hyoungseok_lee@inha.ac.kr
+82-32-890-3575
Time Frame
Start Date: 2025-11-19
Estimated Completion Date: 2028-05
Participants
Target number of participants: 92
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Inha University Hospital
Collaborators: DeepCardio Co., Ltd.

This content was sourced from clinicaltrials.gov