UMIN-CTR Clinical Trial

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
Email	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
Email	gokumura@shinshu-u.ac.jp

Sponsor
Institute	Ministry of Health, Labor and Welfare
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050945