UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044602 |
|---|---|
| Receipt number | R000050945 |
| Scientific Title | A prospective study on the relationship between jugular venous reflux in head MRA and left brachiocephalic vein occlusion |
| Date of disclosure of the study information | 2021/06/25 |
| Last modified on | 2021/06/20 15:21:55 |
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Basic information
Public title
A prospective study on the relationship between jugular venous reflux in head MRA and
left brachiocephalic vein occlusion
Acronym
A prospective study on the relationship between jugular venous reflux in head MRA and
left brachiocephalic vein occlusion
Scientific Title
A prospective study on the relationship between jugular venous reflux in head MRA and
left brachiocephalic vein occlusion
Scientific Title:Acronym
A prospective study on the relationship between jugular venous reflux in head MRA and
left brachiocephalic vein occlusion
Region
| Japan |
Condition
Condition
dural arteriovenous fistulas
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between jugular venous reflux and dural arteriovenous fistulas (dAVF) patient's imaging features and obstruction of the brachiocephalic vein (anonymous vein). A precedent registration study will be conducted for cases in which jugular venous reflux is observed and contrast-enhanced CT and angiography are performed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is to analyze the characteristics of jugular venous reflex patients and to calculate the occlusion of the brachial vein (anonymous vein) or the frequency of both.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A patient who visited our department of neurosurgery and neurosurgery and had a jugular venous reflux on the head MRA taken for the purpose of detailed examination. This includes cases in which urgent cerebral angiography was performed for acute cerebral infarction.
Key exclusion criteria
Exclude cases in which consent to participate in the study cannot be obtained by telephone or in writing from the person or the surrogate, or cases with complete occlusion of the internal carotid artery by MRA.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Gaku |
| Middle name | |
| Last name | Okumura |
Organization
Ina central hospital
Division name
neurology
Zip code
396-8555
Address
Ina City Oaza Ina Koshirokubo
TEL
0265723121
makio_add@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Gaku |
| Middle name | |
| Last name | Okumura |
Organization
Ina central hospital
Division name
neurology
Zip code
396-8555
Address
Ina City Oaza Ina Koshirokubo
TEL
0265723121
Homepage URL
gokumura@shinshu-u.ac.jp
Sponsor or person
Institute
Ministry of Health, Labor and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ina central hospital
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ina central hospital
Address
Ina City Oaza Ina Koshirokubo
Tel
0265723121
info@inahp.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
| 2021 | Year | 06 | Month | 25 | 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
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
no information
Management information
Registered date
| 2021 | Year | 06 | Month | 20 | Day |
Last modified on
| 2021 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050945
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
