UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043437 |
|---|---|
| Receipt number | R000049600 |
| Scientific Title | A Study on Evaluation of Vessel Diameter Using Basi-parallel Anatomical Scanning in Patients with Middle Cerebral Artery Stenosis and Moyamoya Disease |
| Date of disclosure of the study information | 2021/02/25 |
| Last modified on | 2023/09/11 22:36:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Study on Evaluation of Vessel Diameter Using Basi-parallel Anatomical Scanning in Patients with Middle Cerebral Artery Stenosis and Moyamoya Disease
Acronym
A Study on Evaluation of Vessel Diameter Using Basi-parallel Anatomical Scanning in Patients with Middle Cerebral Artery Stenosis and Moyamoya Disease
Scientific Title
A Study on Evaluation of Vessel Diameter Using Basi-parallel Anatomical Scanning in Patients with Middle Cerebral Artery Stenosis and Moyamoya Disease
Scientific Title:Acronym
A Study on Evaluation of Vessel Diameter Using Basi-parallel Anatomical Scanning in Patients with Middle Cerebral Artery Stenosis and Moyamoya Disease
Region
| Japan |
Condition
Condition
Middle cerebral artery stenosis and moyamoya disease
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Basi-parallel anatomical scanning (BPAS) is performed to reveal the external diameter of vessels in patients with narrowing of the middle cerebral artery.
Basic objectives2
Others
Basic objectives -Others
MR anigiography and CT angiography have been able to evaluate the narrowing of the lumen of the middle cerebral artery, but they have not been able to determine whether the vessel itself or only the inner lumen is narrowed. Basi-parallel anatomical scanning (BPAS) is an MRI imaging method used to determine the outer diameter of vessels in basilar arteries, and can be easily performed in about 30 seconds. This imaging method is modified and used for middle cerebral artery imaging.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MRI
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
Patients who meet all of the following criteria
Patients who have been diagnosed with middle cerebral artery stenosis
Patients who have given their consent to join the study (by themselves or their guardians)
Patients who have been judged worthy of evaluation by two doctors
Key exclusion criteria
Patients who are judged by two doctors to be inappropriate for participation in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuya |
| Middle name | |
| Last name | Kobayashi |
Organization
Ina Central Hospital
Division name
Neurology
Zip code
3998655
Address
1313-1, Ina, Nagano
TEL
0265723121
juriruri@inahp.jp
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Kobayashi |
Organization
Ina Central Hospital
Division name
Neurology
Zip code
3998655
Address
1313-1, Ina, Nagano
TEL
0265723121
Homepage URL
juriruri@inahp.jp
Sponsor or person
Institute
Ina Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Ina Central Hospital
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
Ina Central Hospital
Address
1313-1, Ina, Nagano
Tel
0265723121
juriruri@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 | 02 | 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
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 02 | Month | 25 | Day |
Last modified on
| 2023 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049600
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
