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

NCT07540065 | Not Yet Recruiting

• 1 other identifier: 202601103RIND
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation; Stroke; Artificial Intelligence

Keywords

stroke; atrial fibrillation; artificial intelligence; risk prediction; electrocardiogram; non-vitamin K antagonist oral anticoagulants

Outcome Measures

Primary Outcomes (1)

• The difference betwee Active Group & Standard Group

  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

Study Arms (2)

Actively track

EXPERIMENTAL

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

Standard Tracking Group

ACTIVE COMPARATOR

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

Interventions

Active Follow-up Group DEVICE

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.

Also known as: smartwatch, electrocardiogram

Actively track

Standard Follow-up Group OTHER

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.

Also known as: standardized follow-up procedure

Standard Tracking Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous diagnosis of atrial fibrillation or flutter;
• Diagnosis of atrial fibrillation during hospitalization;
• Pre-existing cardiac implantable electronic device (IVD);
• Expected inability to attend regular outpatient follow-ups after discharge, or to undergo multiple 14-day ECG recordings;
• Requires long-term anticoagulant use for other reasons, including but not limited to chronic pulmonary embolism;
• 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;
• Unwilling to sign a participant consent form.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospita

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

Chih-Chieh Yu, MD.PhD

CONTACT

0972652038; sweetchieh@gmail.com

HSIAO-HAN HUANG

CONTACT

clrhuang8853@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective randomized trial will enroll acute ischemic stroke patients with sinus rhythm at admission. Patients will be randomly assigned to either an intensive monitoring group, guided by the AI model, or a standard care group. High-risk patients identified by the AI model will undergo high density, 14-day external single-lead ECG monitoring, analyzed for AF episodes. Both groups will receive standard neurological follow-up. Primary outcomes include new-onset AF detection and recurrent stroke incidence, while secondary outcomes include AF burden, mortality, cognitive function, and healthcare resource utilization.

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: April 20, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

TW (1)