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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032731
Receipt No. R000037328
Scientific Title Demonstration of the Adamkiewicz Artery using time-resolved MRA at 1.5 Tesla
Date of disclosure of the study information 2018/06/01
Last modified on 2019/09/05

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Basic information
Public title Demonstration of the Adamkiewicz Artery using time-resolved MRA at 1.5 Tesla
Acronym Demonstration of the Adamkiewicz Artery using time-resolved MRA
Scientific Title Demonstration of the Adamkiewicz Artery using time-resolved MRA at 1.5 Tesla
Scientific Title:Acronym Demonstration of the Adamkiewicz Artery using time-resolved MRA
Region
Japan

Condition
Condition Thoracoabdominal aortic aneurysm
Classification by specialty
Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate Adamkiewicz artery detectability using time-resolved MRA at 1.5 tesla.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary outcome is a detectability for the Adamkiewcz artery using time-resolved MRA at 1.5 tesla
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
85 years-old >
Gender Male and Female
Key inclusion criteria 1. Patient with descending or thoracoabdominal aortic aneurysm (true aneurysm or dissectional aneurysm).
2. Scheduled for surgical or endovascular aortic replacement.
3. Patient who has underwent CT examination for detection of the Adamkiewicz artery.
4. Ability to provide informed consent
Key exclusion criteria 1. Inability to provide informed consent.
2. Contraindication of MR examination.
3. Implanted with MR conditional pacemaker or ICD
4. Inability to breath holding more than 20 seconds.
5. Contraindication of gadolinium contrast medium
6. Unstable vital sign
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidenobu Takagi
Organization Iwate Medical University
Division name Department of Radiology
Zip code
Address 19-1, Uchimaru, Morioka, Iwate, Japan
TEL 019-651-5111
Email hdnb69tkg@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hidenobu Takagi
Organization Iwate Medical University
Division name Department of Radiology
Zip code
Address 19-1, Uchimaru, Morioka, Iwate, Japan
TEL 019-651-5111
Homepage URL
Email hdnb69tkg@gmail.com

Sponsor
Institute Department of Radiology, Iwate Medical University
Institute
Department

Funding Source
Organization Department of Radiology, Iwate Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor GE Healthcare Japan
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
2018 Year 06 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 0
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 Completed
Date of protocol fixation
2018 Year 07 Month 30 Day
Date of IRB
2018 Year 07 Month 05 Day
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
2019 Year 03 Month 30 Day
Date of closure to data entry
2019 Year 03 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information N/A.

Management information
Registered date
2018 Year 05 Month 26 Day
Last modified on
2019 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037328

Research Plan
Registered date File name
2018/08/14 03_研究計画書_v1.2.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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