UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035715 |
|---|---|
| Receipt number | R000040641 |
| Scientific Title | Investigation of subclavian artery visualization in non-contrast asynchronous MR Angiography |
| Date of disclosure of the study information | 2019/02/13 |
| Last modified on | 2019/02/13 17:28:49 |
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Basic information
Public title
Investigation of subclavian artery visualization in non-contrast asynchronous MR Angiography
Acronym
Investigation of subclavian artery visualization in non-contrast asynchronous MR Angiography
Scientific Title
Investigation of subclavian artery visualization in non-contrast asynchronous MR Angiography
Scientific Title:Acronym
Investigation of subclavian artery visualization in non-contrast asynchronous MR Angiography
Region
| Japan |
Condition
Condition
Subclavian artery stenosis
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
REACT (Reaction (React) (Relaxation Enhanced Angiography without Contrast & Triggering), which is a novel technique for obtaining a clear image of a blood vessel without using a contrast medium and furthermore without having to adjust the timing to the patient's breathing and heartbeat By using it we decided to engage in research to verify the possibility that the burden on the patient is small and clear images can be obtained.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual evaluation
Signal value change
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
expanded access
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Intervention test on MRI examination
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
| 25 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy person
Key exclusion criteria
People without medical history
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | yuka hirose |
Organization
National Hospital Organization Kyushu Medical Center
Division name
Radiation section
Zip code
Address
8th No.1, Chuo-ku, Fukuoka city
TEL
092-852-0700
yuka.h0805@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | yuka hirose |
Organization
National Hospital Organization Kyushu Medical Center
Division name
Radiation section
Zip code
Address
8th No.1, Chuo-ku, Fukuoka city
TEL
092-852-0700
Homepage URL
yuka.h0805@gmail.com
Sponsor or person
Institute
National Hospital Organization Kyushu Medical Center (Clinical Research Center)
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Kyushu Medical Center (Clinical Research Center)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
yhirose-fkok
Org. issuing International ID_1
20190122-185037
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 13 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 30 | Day |
Last modified on
| 2019 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040641
