UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032999 |
|---|---|
| Receipt number | 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 | 2021/02/19 10:29:14 |
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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
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
kensan03977@yahoo.co.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
https://www.nature.com/articles/s41598-020-73658-0
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-020-73658-0
Number of participants that the trial has enrolled
20
Results
The average change in areas from a supine to an upright posture was -77.9% in the right internal jugular vein (IJV), -69.4% in the left IJV, -61.5% in the right external jugular vein (EJV), and -58.9% in the left EJV. In contrast, the change in the anterior condylar vein was approximate +144% on the right and +110% on the left. The posterior venous structures of the craniocervical junction became more prominent in an upright. Despite these changes, the intracranial vessels showed almost no change.
Results date posted
| 2021 | Year | 02 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 10 | Month | 06 | Day |
Baseline Characteristics
Healthy adults between the ages of 30 and 55.
Participant flow
We recruited subjects through a volunteer placement agency.
Adverse events
No adverse events occurred throughout the clinical trial.
Outcome measures
Morphological features of head and neck vascular structures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2021 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037625
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