UMIN-CTR Clinical Trial

Basic information
Public title	Clinical characteristics, management, and prognosis of paradoxical brain embolism related to venous thromboembolism: A multicenter registry
Acronym	Clinical characteristics, management, and prognosis of paradoxical brain embolism
Scientific Title	Clinical characteristics, management, and prognosis of paradoxical brain embolism related to venous thromboembolism: A multicenter registry
Scientific Title:Acronym	Clinical characteristics, management, and prognosis of paradoxical brain embolism
Region	Japan

Condition
Condition	Ischemic stroke
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify clinical characteristics, therapy, and prognosis of paradoxical brain embolism
Basic objectives2	Others
Basic objectives -Others	Multiple infarctions on MRI and prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoints of the study will include the following. (1) Multiple infarctions on MRI at admission. (2) Stroke recurrence after discharge.
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. more than 20 years of age 2. within 7 days of stroke onset 3. diagnosed as RLS on TEE
Key exclusion criteria	1. Patients not undergoing brain MRI
Target sample size	225

Research contact person
Name of lead principal investigator	1st name Ueno Middle name Last name Yuji
Organization	Juntendo University School of Medicine
Division name	Neurology
Zip code	113-8421
Address	Hongo 2-1-1, Bunkyo, Tokyo
TEL	03-3813-3111
Email	yuji-u@juntendo.ac.jp

Public contact
Name of contact person	1st name Yuji Middle name Last name Ueno
Organization	Juntendo University School of Medicine
Division name	Neurology
Zip code	113-8421
Address	Hongo 2-1-1, Bunkyo, Tokyo
TEL	03-3813-3111
Homepage URL
Email	yuji-u@juntendo.ac.jp

Sponsor
Institute	Juntendo University School of Medicine
Institute
Department

Funding Source
Organization	JRISTA The BMS/Pfizer Japan Thrombosis Investigator Initiated Research Program
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	Juntendo University School of Medicine
Address	Hongo 2-1-1, Bunkyo, Tokyo
Tel	03-3813-3111
Email	yuji-u@juntendo.ac.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

Other administrative information
Date of disclosure of the study information	2022 Year 07 Month 13 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	Enrolling by invitation
Date of protocol fixation	2020 Year 03 Month 19 Day
Date of IRB	2020 Year 03 Month 19 Day
Anticipated trial start date	2020 Year 03 Month 19 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Analysis of factors related to multiple cerebral embolism on MRI. Prognosis was also investigated to identify factors involved in recurrence of cerebral infarction, cardiovascular events, and death.

Management information
Registered date	2022 Year 07 Month 13 Day
Last modified on	2022 Year 07 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054646