UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022447 |
|---|---|
| Receipt number | R000025869 |
| Scientific Title | The feasibility of a CT for detection of the artery of Adamkiewicz |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2023/12/01 11:50:59 |
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Basic information
Public title
The feasibility of a CT for detection of the artery of Adamkiewicz
Acronym
CT of the artery of Adamkiewicz
Scientific Title
The feasibility of a CT for detection of the artery of Adamkiewicz
Scientific Title:Acronym
CT of the artery of Adamkiewicz
Region
| Japan |
Condition
Condition
Aortic disease
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diagnostic accuracy of the artery of Adamkiewicz using a beyond 64-row MDCT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy of the artery of Adamkiewicz using a CT
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients evaluated with CT for the detection of the artery of Adamkiewicz
(December, 2008 - May, 2018)
Key exclusion criteria
Patients with contra-indication to CT or iodinated contrast media
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kunihiro |
| Middle name | |
| Last name | Yoshioka |
Organization
Iwate Medical University
Division name
Radiology
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate
TEL
019-613-7111
kyoshi@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Kunihiro |
| Middle name | |
| Last name | Yoshioka |
Organization
Iwate Medical University
Division name
Radiology
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate
TEL
019-613-7111
Homepage URL
kyoshi@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Iwate Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iwate Medical University
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate
Tel
019-613-7111
kenkyu-rinri@j.iwate-med.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
| 2016 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
DOI 10.1007/s00234-017-1927-7
Publication of results
Partially published
Result
URL related to results and publications
DOI 10.1007/s00234-017-1927-7
Number of participants that the trial has enrolled
24
Results
Partially published: The percentage of
patients with non-diagnostic image quality was significantly
lower for ultra-high-resolution CT (8.3%) than for conventional CT (33.3%) (p = 0.03).
Research is continuing toward the final report.
Results date posted
| 2020 | Year | 11 | Month | 27 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Due to COVID-19
Date of the first journal publication of results
| 2017 | Year | 10 | Month | 28 | Day |
Baseline Characteristics
Patients with aortic aneurysm
Participant flow
CT scan before aortic repair
Adverse events
None
Outcome measures
Visualization of the artery of Adamkiewicz
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
To evaluate the diagnostic accuracy of the artery of Adamkiewicz using CT, retrospectively.
Management information
Registered date
| 2016 | Year | 05 | Month | 25 | Day |
Last modified on
| 2023 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025869
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
