UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028197 |
|---|---|
| Receipt number | R000032046 |
| Scientific Title | Relationship between Hemodynamics and Atherosclerosis of the Aorta |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2021/01/25 16:21:15 |
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Basic information
Public title
Relationship between Hemodynamics and Atherosclerosis of the Aorta
Acronym
hemodynamics and atherosclerosis
Scientific Title
Relationship between Hemodynamics and Atherosclerosis of the Aorta
Scientific Title:Acronym
hemodynamics and atherosclerosis
Region
| Japan |
Condition
Condition
vascular diseases
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Vascular surgery |
| Radiology | Cardiovascular surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test if hemodynamic assessment using phase contrast MR can predict or find initial pathologies of atherosclerosis in the aorta.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The streamline analysis, WSS, OSI or GON derived from velocity data as well as the CFD simulation are correlated with FDG-PET accumulation in the aortic wall.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants of annual health check up who agreed to join the study.
Key exclusion criteria
MR contraindicated.
Individual with known aortic diseases or those
who operated on.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Takehara |
Organization
Nagoya University, Graduate School of Medicine
Division name
Department of Fundamental Development for Advanced Low Invasive Diagnostic Imaging
Zip code
466-8550
Address
65 Tsurumai-cho, Shouwa-ku, Nagoya 466-8550 Japan
TEL
052-744-2327
takehara@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuo |
| Middle name | |
| Last name | Takehara |
Organization
Nagoya University, Graduate School of Medicine
Division name
Department of Fundamental Development for Advanced Low Invasive Diagnostic Imaging
Zip code
466-8550
Address
65 Tsurumai-cho, Shouwa-ku, Nagoya 466-8550 Japan
TEL
(052)744-2327
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
Nagoya university graduate school of medicine
Address
tsurumaicho 65, shouwa-ku, nagoya, aichi, japan
Tel
0537412111
iga-kenkyu@adm.nagoya-u.ac.jp
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 | 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
Suspended
Date of protocol fixation
| 2017 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
flow velocities and other parameters derived from 4D Flow are to be compared to FDG-PET reuslts.
Management information
Registered date
| 2017 | Year | 07 | Month | 12 | Day |
Last modified on
| 2021 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032046
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/01/17 | 研究計画概要書 4.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
