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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027568
Receipt No. R000030910
Scientific Title Hemodynamic analysis of human vessels using three dimensional cine phase contrast magnetic resonance imaging
Date of disclosure of the study information 2017/06/30
Last modified on 2019/01/17

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Basic information
Public title Hemodynamic analysis of human vessels using three dimensional cine phase contrast magnetic resonance imaging
Acronym Hemodynamic assessments of human using 4D Flow
Scientific Title Hemodynamic analysis of human vessels using three dimensional cine phase contrast magnetic resonance imaging
Scientific Title:Acronym Hemodynamic assessments of human using 4D Flow
Region
Japan

Condition
Condition vascular diseases
Classification by specialty
Cardiology Vascular surgery Radiology
Cardiovascular surgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 flow velocities and other parameters derived from 4D Flow and MR angiography are to be compared between normal and diseased vessels and 2) between normal and diseased subjects.
Basic objectives2 Others
Basic objectives -Others comparison between pathological and normal
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes flow velocity
Key secondary outcomes streamline
pathline
ossillatory shear index
gradient oscillatory number

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Medicine Device,equipment
Interventions/Control_1 magnetic resonance imaging
Interventions/Control_2 contrast enhancement
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 candidate for abdominal magnetic resonance imaging.
Key exclusion criteria contraindicated patients for magnetic resonance or contrast administration
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Takehara
Organization Nagoya University, Graduate School of Medicine
Division name Department of Fundamental Development for Advanced Low Invasive Diagnostic Imaging
Zip code
Address 65 Tsurumai-cho, Shouwa-ku, Nagoya 466-8550 Japan
TEL 0527442327
Email takehara@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuo Takehara
Organization Nagoya University, Graduate School of Medicine
Division name Department of Fundamental Development for Advanced Low Invasive Diagnostic Imaging
Zip code
Address 65 Tsurumai-cho, Shouwa-ku, Nagoya 466-8550 Japan
TEL 0527442327
Homepage URL
Email takehara@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University, Graduate School of Medicine
Institute
Department

Funding Source
Organization Himedic Nagoya
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 06 Month 30 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 Enrolling by invitation
Date of protocol fixation
2017 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 01 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
2017 Year 05 Month 31 Day
Last modified on
2019 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030910

Research Plan
Registered date File name
2019/01/17 研究計画概要書4 (1).doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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