UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033327 |
|---|---|
| Receipt number | 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 21:41:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
h-ota@rad.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037990
