UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032957 |
|---|---|
| Receipt number | R000037573 |
| Scientific Title | Mechanisms of Embolic Stroke Clarified by Transesophageal Echocardiography for Embolic Stroke of Undetermined Source/Cryptogenic Stroke |
| Date of disclosure of the study information | 2018/06/12 |
| Last modified on | 2018/11/08 10:16:44 |
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Basic information
Public title
Mechanisms of Embolic Stroke Clarified by Transesophageal Echocardiography for Embolic Stroke of Undetermined Source/Cryptogenic Stroke
Acronym
CHALLENGE ESUS/CS
Scientific Title
Mechanisms of Embolic Stroke Clarified by Transesophageal Echocardiography for Embolic Stroke of Undetermined Source/Cryptogenic Stroke
Scientific Title:Acronym
CHALLENGE ESUS/CS
Region
| Japan |
Condition
Condition
Cryptogenic stroke/Embolic stroke of undetermined source
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the mechanisms of cryptogenic stroke/embolic stroke of undetermined source
Basic objectives2
Others
Basic objectives -Others
To clarify potential embolic sources by transesophageal echocardiography in cryptogenic stroke/embolic stroke of undetermined source
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prognosis
Key secondary outcomes
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. Acute ischemic stroke within 7 days of onset
2. Cryptogenic stroke/Embolic stroke of undetermined source
a. Non-lacunar stroke demonstrated on CT or MRI
b. Absence of the extracranial or intracranial atherosclerosis causing >50% luminal stenosis in the corresponded arteries
c. Absence of major cardiac embolic diseases
d. Lack of other determined stroke etiologies
Key exclusion criteria
Patients considered as inappropriate by investigators
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Ueno |
Organization
Juntendo University Faculty of Medicine
Division name
Neurology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
03-3813-3111
yuji-u@juntendo.ac.jo
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Ueno |
Organization
Juntendo University Faculty of Medicine
Division name
Neurology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
03-3813-3111
Homepage URL
yuji-u@juntendo.ac.jo
Sponsor or person
Institute
Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 12 | 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
| 2017 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective cohort study
Management information
Registered date
| 2018 | Year | 06 | Month | 12 | Day |
Last modified on
| 2018 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037573
