UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027568 |
|---|---|
| Receipt number | 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 12:12:23 |
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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
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
takehara@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University, Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030910
