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

N/ANot Yet RecruitingNCT07540065

National Taiwan University Hospital400 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

400

Conditions

Atrial Fibrillation

Interventions

Active Follow-up GroupDEVICE

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 GroupOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: 400DAYS