Enhanced Detection of Underlying, Covert ATrial Fibrillation Using 7-day Holter Electrocardiogram in Patients With Embolic Stroke of Undetermined Source (EDUCATE-ESUS)
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ClinicalTrials.gov Identifier: NCT02801708
Recruitment Status : Unknown
Verified December 2016 by Yuichi Miyazaki, National Cerebral and Cardiovascular Center. Recruitment status was: Recruiting
First Posted : June 16, 2016
Last Update Posted : December 2, 2016
National Cerebral and Cardiovascular Center
Information provided by (Responsible Party):
Yuichi Miyazaki, National Cerebral and Cardiovascular Center
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.
Condition or disease
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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Layout table for eligibility information
Ages Eligible for Study:
20 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with recent embolic stroke of undetermined source
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
Previously documented atrial fibrillation
Pacemaker or implantable cardioverter defibrillator implanted or planned to implant
Estimated life expectancy < 12 months
Examination of seven-day Holter ECG not applicable within 3 months after stroke onset.
Patients considered inappropriate to participate in the study