NCT07347691 AI-Based Prediction of Atrial Fibrillation in ESUS Patients With ICM
| NCT ID | NCT07347691 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Inha University Hospital |
| Condition | Embolic Stroke of Undetermined Source |
| Study Type | OBSERVATIONAL |
| Enrollment | 92 participants |
| Start Date | 2025-11-19 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 92 participants in total. It began in 2025-11-19 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Yong-Soo Baek, MD, PhD
PRINCIPAL INVESTIGATOR
Inha University Hospital
Frequently Asked Questions
Who can join the NCT07347691 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, studying Embolic Stroke of Undetermined Source. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07347691 currently recruiting?
Yes, NCT07347691 is actively recruiting participants. Contact the research team at existsoo@inha.ac.kr for enrollment information.
Where is the NCT07347691 trial being conducted?
This trial is being conducted at Ansan, South Korea, Incheon, South Korea, Jeju City, South Korea, Seoul, South Korea and 1 additional location.
Who is sponsoring the NCT07347691 clinical trial?
NCT07347691 is sponsored by Inha University Hospital. The principal investigator is Yong-Soo Baek, MD, PhD at Inha University Hospital. The trial plans to enroll 92 participants.
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