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Enhanced Detection of Underlying, Covert ATrial fibrillation using 7-day Holter Electrocardiogram in patients with Embolic Stroke of Undetermined Source

Enhanced Detection of Underlying, Covert ATrial fibrillation using 7-day Holter Electrocardiogram in patients with Embolic Stroke of Undetermined Source - EDUCATE-ESUS

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000019170
Enrollment
200
Registered
2015-10-01
Start date
2014-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Embolic stroke of undetermined source

Interventions

None listed

Sponsors

National Cerebral and Cardiovascular Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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. Absence of cervical carotid atherosclerotic stenosis > 50% or occlusion C. No atrial fibrillation after 24-hour cardiac rhythm 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

Exclusion criteria: 1. Any previously documented atrial fibrillation 2. Untreated hyperthyroidism 3. Pacemaker or ICD device 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

MeasureTime frame
Detection of any atrial fibrillation by 7-day Holter ECG

Secondary

MeasureTime frame
1. Antithrombotic therapy before and after 7-day Holter ECG 2. Any ischemic or hemorrhagic event for 1 year after index stroke 3. Any adverse event related to 7-day Holter ECG

Countries

Japan

Contacts

Public ContactMiyazaki Yuichi

National Cerebral and Cardiovascular Center Department of Cerebrovascular Disease

ymiyazaki@ncvc.go.jp06-6833-5012

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026