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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032957
Receipt No. R000037573
Official scientific title of the study MeCHAnisms of emboLic stroke cLarifiEd by traNsesophaGeal Echocardiography for Cryptogenic Stroke
Date of disclosure of the study information 2018/06/12
Last modified on 2018/06/12

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Basic information
Official scientific title of the study MeCHAnisms of emboLic stroke cLarifiEd by traNsesophaGeal Echocardiography for Cryptogenic Stroke
Title of the study (Brief title) CHALLENGE-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 Yuji Ueno
Organization Juntendo University Faculty of Medicine
Division name Neurology
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL 03-3813-3111
Email yuji-u@juntendo.ac.jo

Public contact
Name of contact person Yuji Ueno
Organization Juntendo University Faculty of Medicine
Division name Neurology
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL 03-3813-3111
Homepage URL
Email yuji-u@juntendo.ac.jo

Sponsor
Institute Juntendo University Faculty of Medicine
Institute
Department

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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 03 Month 30 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Retrospective cohort study

Management information
Registered date
2018 Year 06 Month 12 Day
Last modified on
2018 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037573

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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