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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032999
Receipt No. R000037625
Scientific Title Evaluation of anatomical structure and vascular flow of craniocervical vessels by using the upright-position computed tomography compared with supine position.
Date of disclosure of the study information 2018/06/15
Last modified on 2019/06/18

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Basic information
Public title Evaluation of anatomical structure and vascular flow of craniocervical vessels by using the upright-position computed tomography compared with supine position.
Acronym Evaluation of anatomical structure and vascular flow of craniocervical vessels by using the upright-position computed tomography compared with supine position.
Scientific Title Evaluation of anatomical structure and vascular flow of craniocervical vessels by using the upright-position computed tomography compared with supine position.
Scientific Title:Acronym Evaluation of anatomical structure and vascular flow of craniocervical vessels by using the upright-position computed tomography compared with supine position.
Region
Japan

Condition
Condition normal volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Craniocervical contrast enhanced computed tomographies are taken at the supine and sitting position for male and female normal volunteers from 30 to 80 years. From the results, the anatomical structure, flow, and perfusion of those vessels at the sitting position are evaluated by comparing with supine-position CT.
Basic objectives2 Others
Basic objectives -Others Explanation of changes in anatomy and blood flow of craniocervical veins by postural changes.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diameter and blood flow of superior sagittal sinus, straight sinus, transverse sinus, sigmoid sinus, confluence, internal jugular vein, external jugular vein, superior petrosal sinus, and inferior petrosal sinus.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 take the contrast-enhanced computed tomography at supine position and sitting position
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
30 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Male and female healthy volunteers from 30s to 80s who understand this clinical research
Key exclusion criteria 1. pregnant women and women with possibility of pregnancy
2. those who have and had asthma
3. those who have a side effect history on iodine contrast agent
4. persons with impaired renal function
5. persons with symptoms of some kinds of disease
6. those who cannot undergo supine position CT or sitting position CT
7. those whose consent to this clinical trial cannot be obtained
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Jinzaki
Organization Keio University School of Medicine
Division name Radiology
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582
TEL (03)-3353-1211
Email jinzaki@rad.med.keio.ac.jp

Public contact
Name of contact person
1st name Kenzo
Middle name
Last name Kosugi
Organization Keio University School of Medicine
Division name Neurosurgery
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582
TEL (03)-3353-1211
Homepage URL
Email kensan03977@yahoo.co.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Keio University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Keio University School of Medicine
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582
Tel 62014
Email med-rinri-jimu@adst.keio.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
2018 Year 06 Month 15 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 20
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 No longer recruiting
Date of protocol fixation
2018 Year 06 Month 15 Day
Date of IRB
2018 Year 06 Month 12 Day
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 15 Day
Last modified on
2019 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037625

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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