UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027462 |
|---|---|
| Receipt number | R000031463 |
| Scientific Title | Comparative study of Cartesian and non-Cartesian acquisition technique in three-dimensional cine phase contrast magnetic resonance imaging (3D cine PC MRI) for analysis of blood flow dynamics within human vessels. |
| Date of disclosure of the study information | 2017/05/23 |
| Last modified on | 2017/11/22 11:14:58 |
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Basic information
Public title
Comparative study of Cartesian and non-Cartesian acquisition technique in three-dimensional cine phase contrast magnetic resonance imaging (3D cine PC MRI) for analysis of blood flow dynamics within human vessels.
Acronym
Comparative study of 4D-flow and PC-VIPR.
Scientific Title
Comparative study of Cartesian and non-Cartesian acquisition technique in three-dimensional cine phase contrast magnetic resonance imaging (3D cine PC MRI) for analysis of blood flow dynamics within human vessels.
Scientific Title:Acronym
Comparative study of 4D-flow and PC-VIPR.
Region
| Japan |
Condition
Condition
Aortic artery
Classification by specialty
| Vascular surgery | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There are mainly two different techniques used for acquisition of 3D cine PC MR data; Cartesian acquisition technique and non-Cartesian radial acquisition technique.
Recently GE healthcare company has brought out a 3D cine PC MRI sequence that uses Cartesian acquisition technique. This sequence was based on a Cartesian 3D cine PC MRI developed by Stanford University, which is called 4D Flow in a narrow sense. Wisconsin University has also developed a 3D cine PC MRI with non-Cartesian radial data acquisition called PC-VIPR.
The purpose of this joint study is to compare and investigate the consistency of the 3D cine PC MRI data using the Cartesian methods and the non-Cartesian method.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Flow velocity within blood vessels, and various flow dynamics parameters (wall shear stress, oscillatory shear index, gradient oscillatory number) derived from the datasets of two 4DFlow sequences and PC-VIPR.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
The three-dimensional cine phase contrast magnetic resonance imaging using Cartesian method.
Interventions/Control_2
The three-dimensional cine phase contrast magnetic resonance imaging using non-Cartesian method.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy volunteer who is twenty years old or older, with written informed concent.
Key exclusion criteria
1.People who can not take MRI(for example,people who have claustrophobia,devices which is unsupported for MRI,etc)
2. People who have past history of cardiovascular or arterial disease.
3. People who have past history of operation, stentgraft, metallic coil in the imaging area.
4.Woman who is pregnant or may be pregnant
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takasuke Ushio |
Organization
Hamamatsu Univercity school of medicine
Division name
Department of diagnostic radiology and nuclear medicine
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan 431-3192
TEL
053-435-2242
tushio@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takasuke Ushio |
Organization
Hamamatsu Univercity school of medicine
Division name
Department of diagnostic radiology and nuclear medicine
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan 431-3192
TEL
053-435-2242
Homepage URL
tushio@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu Univercity school of medicine
Institute
Department
Personal name
Funding Source
Organization
GE Healthcare Japan
Organization
Division
Category of Funding Organization
Profit organization
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
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
| 2017 | Year | 05 | Month | 23 | 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
| 2016 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
| 2017 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 23 | Day |
Last modified on
| 2017 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031463
