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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028197
Receipt No. R000032046
Scientific Title Relationship between Hemodynamics and Atherosclerosis of the Aorta
Date of disclosure of the study information 2017/08/01
Last modified on 2018/07/17

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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
Last 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 052-744-2327
Email takehara@med.nagoya-u.ac.jp

Public contact
1st 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 (052)744-2327
Homepage URL
Email takehara@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University, Graduate School of Medicine
Institute
Department

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
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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 28 Day
Last follow-up date
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
2018 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.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


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