UMIN-CTR Clinical Trial

Basic information
Public title	Enhanced Detection of Underlying, Covert ATrial fibrillation using 7-day Holter Electrocardiogram in patients with Embolic Stroke of Undetermined Source
Acronym	EDUCATE-ESUS
Scientific Title	Enhanced Detection of Underlying, Covert ATrial fibrillation using 7-day Holter Electrocardiogram in patients with Embolic Stroke of Undetermined Source
Scientific Title:Acronym	EDUCATE-ESUS
Region	Japan

Condition
Condition	Embolic stroke of undetermined source
Classification by specialty	Medicine in general Cardiology Neurology Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the diagnostic yield of continuous 7-day Holter ECG for detecting covert paroxysmal atrial fibrillation in patients with recent embolic stroke or TIA of undetermined cause after completion of a standard clinical work-up (including an initial 24-hour Holter ECG.)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection of any atrial fibrillation by 7-day Holter ECG
Key secondary outcomes	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

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Miyazaki Middle name Last name Yuichi
Organization	National Cerebral and Cardiovascular Center
Division name	Department of Cerebrovascular Disease
Zip code	564-8565
Address	5-7-1 Fujishirodai, Suita, Osaka, Japan
TEL	06-6833-5012
Email	ymiyazaki@ncvc.go.jp

Public contact
Name of contact person	1st name Miyazaki Middle name Last name Yuichi
Organization	National Cerebral and Cardiovascular Center
Division name	Department of Cerebrovascular Disease
Zip code	564-8565
Address	5-7-1 Fujishirodai, Suita, Osaka, Japan
TEL	06-6833-5012
Homepage URL
Email	ymiyazaki@ncvc.go.jp

Sponsor
Institute	National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization	National Cerebral and Cardiovascular Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Cerebral and Cardiovascular Center
Address	5-7-1 Fujishirodai, Suita, Osaka, Japan
Tel	06-6833-5012
Email	m.sio@ncvc.go.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立循環器病研究センター　脳血管内科/脳神経内科（大阪府）、 東京慈恵会医科大学　神経内科（東京都）、 弘前脳卒中・リハビリテーションセンター　内科（青森県）、 杏林大学　脳卒中医学教室（東京都） 国立病院機構九州医療センター　脳血管・神経内科（福岡県）

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date	2014 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Study design : Multi-center prospective observational study Study subjects : Patients who were diagnosed with ESUS at the participating centers between August 2014 and March 2016.

Management information
Registered date	2015 Year 09 Month 30 Day
Last modified on	2020 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022160