AI-Assisted Workflow for Occult Atrial Fibrillation Detection After Ischemic Stroke: A Prospective Randomized Trial (AI-AFIS)

April 16, 2026 updated by: National Taiwan University Hospital
We hypothesize that an AI-guided AF risk stratification approach, particularly when combined with intensified rhythm monitoring using wearable devices and extended ECG patches, will significantly increase AF detection rates compared with standard care. By enabling earlier identification of patients who may benefit from anticoagulation therapy, this strategy has the potential to improve clinical outcomes while minimizing unnecessary exposure to anticoagulant-related bleeding risks. Ultimately, this trial seeks to provide robust clinical evidence supporting the integration of AI-assisted ECG analysis into routine post-stroke care, advancing precision medicine and optimizing resource allocation for patients with ischemic stroke.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is designed as a multicenter, prospective, randomized controlled trial enrolling adult patients hospitalized for acute ischemic stroke who demonstrate sinus rhythm on admission 12-lead ECG. Participants will be randomized to either an AI-assisted care group or a usual-care control group, and further allocated to active or standard rhythm monitoring strategies. The primary endpoint is the incidence of newly diagnosed AF or atrial flutter within six months, defined by electrocardiographic documentation. Secondary and exploratory endpoints include the rate of oral anticoagulant initiation, AF burden metrics, recurrent embolic events, bleeding complications, major adverse cardiovascular events, cognitive outcomes, and all-cause mortality.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 18 years or older who are acutely hospitalized due to ischemic stroke;
  2. A 12-lead electrocardiogram upon admission showing sinus rhythm;

Exclusion Criteria:

  1. Previous diagnosis of atrial fibrillation or flutter;
  2. Diagnosis of atrial fibrillation during hospitalization;
  3. Pre-existing cardiac implantable electronic device (IVD);
  4. Expected inability to attend regular outpatient follow-ups after discharge, or to undergo multiple 14-day ECG recordings;
  5. Requires long-term anticoagulant use for other reasons, including but not limited to chronic pulmonary embolism;
  6. Known contraindications to non-vitamin K antagonist oral anticoagulants due to comorbidities, including but not limited to end-stage renal disease, severe mitral stenosis due to rheumatic heart disease, or metallic heart valves;
  7. Unwilling to sign a participant consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Actively track
High-frequency electrocardiogram (ECG) monitoring was conducted, using a smartwatch with continuous photoplethysmography (PPG) and an external monopolar ECG patch for 14 days. Subjects recorded ECGs for 14 days immediately after discharge. If the smartwatch detected atrial fibrillation, it would automatically apply the ECG patch for 14 days to record the data. After recording, the data was mailed or delivered in person to the research team for analysis.
Device: Active Follow-up Group
High-frequency electrocardiogram (ECG) monitoring was conducted, using a smartwatch with continuous photoplethysmography (PPG) monitoring, supplemented by an external single-lead ECG patch for 14 days. Participants recorded ECGs for 14 days immediately after discharge. If the smartwatch detected atrial fibrillation, the patch would be automatically applied for 14 days of recording. After recording, the patch was mailed or delivered in person to the research team for analysis.
Other Names:
  • electrocardiogram
  • smartwatch
Active Comparator: Standard Tracking Group
Following the standardized follow-up procedure for neurologists, each follow-up visit includes a medical history and physical examination, without further cardiac-related monitoring. However, if the patient has symptoms of arrhythmia, the physician may consult a cardiologist or perform a preliminary 12-lead electrocardiogram.
Other: Standard Follow-up Group
followed a standardized follow-up procedure by a neurologist. Each follow-up visit included a medical history and physical examination, without further cardiac-related monitoring. However, if the patient presented with symptoms of arrhythmia, the physician could consult a cardiologist or perform a preliminary 12-lead ECG.
Other Names:
  • standardized follow-up procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference betwee Active Group & Standard Group
Time Frame: 400DAYS
The difference between the probability of a new diagnosis of atrial fibrillation or atrial flutter within six months (defined as an atrial fibrillation waveform longer than 30 seconds on a single-lead ECG or a twelve-lead ECG) in subjects identified as high-risk in the AI-assisted group and those who were actively followed up (Group A) and those who were followed up according to standard care (Group D).
400DAYS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

January 7, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202601103RIND

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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