UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032731 |
|---|---|
| Receipt number | 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 13:24:06 |
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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
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
hdnb69tkg@gmail.com
Sponsor or person
Institute
Department of Radiology, Iwate Medical University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
