UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019170 |
|---|---|
| Receipt number | R000022160 |
| Scientific Title | Enhanced Detection of Underlying, Covert ATrial fibrillation using 7-day Holter Electrocardiogram in patients with Embolic Stroke of Undetermined Source |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2020/04/20 11:43:40 |
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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
Interventions/Control_4
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
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
ymiyazaki@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022160
