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The aim of this study is to determine the diagnostic yield of continuous 7-day Holter ECG for detecting covert paroxysmal atrial fibrillation in patients with recent embolic stroke or transient ischemic attack (TIA) of undetermined cause after completion of a standard clinical work up including an initial 24-hour Holter monitoring.
Covert atrial fibrillation (AF) is a relevant potential cause of a recently proposed clinical construct, "Embolic Stroke of Undetermined Source (ESUS)". However, routine post-stroke work up including 24-hour Holter monitoring may fail to detect paroxysmal AF. A recent systematic review has shown an increased AF detection rate with longer monitoring durations. The aim of this study is to evaluate the effectiveness of a novel ambulatory 7-day Holter ECG (EV-201, Parama-Tech inc.) for detecting AF in patients with recent ESUS after completion of a standard clinical examination.
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| Measure | Description | Time Frame |
|---|---|---|
| Detection of any atrial fibrillation | After examination of 7-day Holter monitoring (within 90 days of stroke onset) |
| Measure | Description | Time Frame |
|---|---|---|
| Change of antithrombotic drugs | After the examination of 7-day Holter monitoring | |
| Any ischemic or hemorrhagic event | 365 days after index stroke | |
| Any adverse event related to 7-day Holter monitoring |
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Inclusion Criteria:
Recent ESUS (within 3 months of onset) defined as:
A. Recent ischemic stroke (including transient ischemic attack with positive neuroimaging) visualized by brain imaging that is not lacunar B. Abscence of ≥ 50% stenosis or occlusion in cervical and intracranial arteries supplying ischemic area C. No atrial fibrillation after ≥ 24-hour Holter monitoring D. No intra-cardiac thrombus on transthoracic echocardiography E. No other major cardioembolic sources F. No other specific cause of stroke (for example, arteritis, dissection, migraine/vasospasm, drug abuse)
20 years of age or older
Signed written informed consent
Exclusion Criteria:
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Patients with recent embolic stroke of undetermined source
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuichi Miyazaki, MD | Contact | 81-6-6833-5012 | ymiyazaki@ncvc.go.jp |
| Name | Affiliation | Role |
|---|---|---|
| Yuichi Miyazaki, MD | National Cerebral and Cardiovascular Center, Japan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cerebral and Cardiovascular Center | Recruiting | Suita | Osaka | 565-8565 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32801289 | Derived | Miyazaki Y, Toyoda K, Iguchi Y, Hirano T, Metoki N, Tomoda M, Shiozawa M, Koge J, Okada Y, Terasawa Y, Kikuno M, Okano H, Hagii J, Nakajima M, Komatsu T, Yasaka M. Atrial Fibrillation After Ischemic Stroke Detected by Chest Strap-Style 7-Day Holter Monitoring and the Risk Predictors: EDUCATE-ESUS. J Atheroscler Thromb. 2021 May 1;28(5):544-554. doi: 10.5551/jat.58420. Epub 2020 Aug 15. |
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| After the examination of 7-day Holter monitoring |
| Time to detection of atrial fibrillation on 7-day Holter monitoring | After the examination of 7-day Holter monitoring |
| Atrial fibrillation burden | defined as the total time in atrial fibrillation devided by the total monitored time | After the examination of 7-day Holter monitoring |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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