UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Hideki Ota
Organization	Tohoku university hospital
Division name	Department of radiology
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	Hideki Ota
Organization	Tohoku university hospital
Division name	Department of radiology
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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