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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027462
Receipt No. 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

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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
Email 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
Email tushio@hama-med.ac.jp

Sponsor
Institute Hamamatsu Univercity school of medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031463

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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