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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Другое 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.

Первичные конечные точки

• The difference betwee Active Group & Standard Group [Срок оценки: 400DAYS]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Тайвань · 1 центр

• National Taiwan University Hospita — Taipei

Идентификаторы

NCT: NCT07540065 · 202601103RIND

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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