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AI tool aims to spot hidden AFib risk in stroke patients

NCT ID NCT07347691

Knowledge-focused Sponsor: Inha University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at 92 people who had a stroke with no clear cause and received a small heart monitor. Researchers will use an artificial intelligence program called SmartECG-AF to analyze their ECGs and predict who might develop atrial fibrillation (an irregular heartbeat) in the future. The goal is to see if the AI can accurately separate high-risk patients from lower-risk ones, which could help doctors prevent future strokes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Artificial intelligence ECG analysis (SmartECG-AF)
What this could lead to
If successful, this could lead to a simple AI-based method to identify stroke patients at high risk for atrial fibrillation, enabling earlier treatment and prevention of future strokes.
What could go wrong
This is a small, early-stage study (92 participants) that only observes and analyzes data—it does not test a new treatment. The AI tool may not prove accurate enough for widespread use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 92 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

30 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

intracranial embolism Ischemic Stroke stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Embolic stroke of undetermined source

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ajou University Hospital

    RECRUITING

    Suwon, South Korea

  • Inha University Hospital

    RECRUITING

    Incheon, South Korea

  • Jeju National University Hospital

    RECRUITING

    Jeju City, South Korea

  • Korea University Ansan Hospital

    RECRUITING

    Ansan, South Korea

  • Korea University Guro Hospital

    RECRUITING

    Seoul, South Korea

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