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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033327
Receipt No. R000037990
Scientific Title Evaluation of hemodynamics in the aorta and main branches using 4D flow imaging in healthy volunteers, comparison with CFD hemodynamic simulation and creation of appropriate CFD hemodynamic model.
Date of disclosure of the study information 2018/08/01
Last modified on 2018/07/08

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Basic information
Public title Evaluation of hemodynamics in the aorta and main branches using 4D flow imaging in healthy volunteers, comparison with CFD hemodynamic simulation and creation of appropriate CFD hemodynamic model.
Acronym Evaluation of hemodynamics using 4D flow imaging in healthy volunteers, comparison and creation of CFD hemodynamic simulation model.
Scientific Title Evaluation of hemodynamics in the aorta and main branches using 4D flow imaging in healthy volunteers, comparison with CFD hemodynamic simulation and creation of appropriate CFD hemodynamic model.
Scientific Title:Acronym Evaluation of hemodynamics using 4D flow imaging in healthy volunteers, comparison and creation of CFD hemodynamic simulation model.
Region
Japan

Condition
Condition healthy adult volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of hemodynamics in the aorta and main branches using 4D flow MRI and comparison with CFD hemodynamic simulation.
Basic objectives2 Others
Basic objectives -Others Creation of appropriate CFD hemodynamic model
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference of hemodynamic parameters between 4D flow MRI and CFD simulation.
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
20 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthy adult volunteer
Key exclusion criteria Person who cannot take MR examination due to metal in the body or claustrophobia
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Ota
Organization Tohoku university hospital
Division name Department of radiology
Zip code
Address 1-1 Seiryo Aoba Sendai Miyagi
TEL 022-717-7312
Email h-ota@rad.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Ota
Organization Tohoku university hospital
Division name Department of radiology
Zip code
Address 1-1 Seiryo Aoba Sendai Miyagi
TEL 022-717-7312
Homepage URL
Email h-ota@rad.med.tohoku.ac.jp

Sponsor
Institute Tohoku university
Institute
Department

Funding Source
Organization Tohoku university
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
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
2018 Year 08 Month 01 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 Preinitiation
Date of protocol fixation
2018 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information preinitiation state

Management information
Registered date
2018 Year 07 Month 08 Day
Last modified on
2018 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037990

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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