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

Sponsor
National Taiwan University Hospital
Study ID
NCT07540065
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Apr 20, 2026
Start date
Oct 1, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • 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.
  • 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.

Primary Outcome Measure

The difference betwee Active Group & Standard Group [ Time Frame: 400DAYS ]

Central Contacts

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