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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chih-Chieh Yu, MD.PhD | Contact | 0972652038 | sweetchieh@gmail.com | |
| HSIAO-HAN HUANG | Contact | clrhuang8853@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospita | Taipei | 100 | Taiwan |
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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.
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| 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. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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