UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026309 |
|---|---|
| Receipt number | R000030214 |
| Scientific Title | A retrospective observational study of the risk factors for abdominal aortic aneurysm expansion |
| Date of disclosure of the study information | 2017/02/26 |
| Last modified on | 2017/07/05 16:15:04 |
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Basic information
Public title
A retrospective observational study of the risk factors for abdominal aortic aneurysm expansion
Acronym
A retrospective observational study of the risk factors for abdominal aortic aneurysm expansion
Scientific Title
A retrospective observational study of the risk factors for abdominal aortic aneurysm expansion
Scientific Title:Acronym
A retrospective observational study of the risk factors for abdominal aortic aneurysm expansion
Region
| Japan |
Condition
Condition
abdominal aortic aneurysm
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To deduce risk factors for abdominal aortic aneurysm expansion
Basic objectives2
Others
Basic objectives -Others
Exploratory research of abdominal aortic aneurysm exoansion
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Abdominal aortic aneurysm expansion rate defined as the difference in the maximum short axis diameter between the follow-up and initial computed tomography scans divided by the interval between the scans and was expressed in a unit of mm/year
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
Patients with infrarenal and fusiform abdominal aortic aneurysms who had either undergone surgery for an abdominal aortic aneurysm or who were being followed up for small-diameter abdominal aortic aneurysm at Tohoku University Hospital from April 2012 to March 2016, and who had undergone at least two computed tomography scan
Key exclusion criteria
We excluded patients with inflammatory, infectious, or saccular abdominal aortic aneurysms, patients with inherited vascular disorders, such as Marfan syndrome, and patients on dialysis.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Goto |
Organization
Tohoku University Hospital
Division name
Department of Transplantation, Reconstruction and Endoscopic Surgery
Zip code
Address
1-1 Seiryo-cho, Aoba-ku, Sendai city, 980-8574, Japan
TEL
022-717-7214
h-goto@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuta Tajima |
Organization
Tohoku University Hospital
Division name
Department of Transplantation, Reconstruction and Endoscopic Surgery
Zip code
Address
1-1 Seiryo-cho, Aoba-ku, Sendai city, 980-8574, Japan
TEL
022-717-7214
Homepage URL
http://www.med.tohoku.ac.jp/public/doc/2016-1-481.pdf
yuta_taji_1061@msc.biglobe.ne.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2017 | Year | 02 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://doi.org/10.1253/circj.CJ-16-0902
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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2017 | Year | 02 | Month | 25 | Day |
Last modified on
| 2017 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030214
