UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048371 |
|---|---|
| Receipt number | R000054646 |
| Scientific Title | Clinical characteristics, management, and prognosis of paradoxical brain embolism related to venous thromboembolism: A multicenter registry |
| Date of disclosure of the study information | 2022/07/13 |
| Last modified on | 2022/07/13 19:13:18 |
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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
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
yuji-u@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054646
