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

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.

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.

Interventions

• 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 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.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

Taiwan · 1 center

• National Taiwan University Hospita — Taipei

Identifiers

NCT: NCT07540065 · 202601103RIND

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗