Stroke
Conditions
Keywords
Embolic stroke of undetermined source, Atrial fibrillation
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
National Cerebral and Cardiovascular Center, Japan
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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) 2. 20 years of age or older 3. Signed written informed consent
Exclusion criteria
1. Previously documented atrial fibrillation 2. Untreated hyperthyroidism 3. Pacemaker or implantable cardioverter defibrillator implanted or planned to implant 4. Estimated life expectancy \< 12 months 5. Examination of seven-day Holter ECG not applicable within 3 months after stroke onset. 6. Patients considered inappropriate to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection of any atrial fibrillation | After examination of 7-day Holter monitoring (within 90 days of stroke onset) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | After the examination of 7-day Holter monitoring | defined as the total time in atrial fibrillation devided by the total monitored time |
Countries
Japan
Contacts
Primary ContactYuichi Miyazaki, MD
Outcome results
None listed