UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046559 |
|---|---|
| Receipt number | R000053120 |
| Scientific Title | The survey of the index of arterial sitffness to predict the progression of aortic aneurysm |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2023/09/22 15:52:26 |
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Basic information
Public title
The survey of the index of arterial sitffness to predict the progression of aortic aneurysm
Acronym
The survey of the index of arterial sitffness to predict the progression of aortic aneurysm
Scientific Title
The survey of the index of arterial sitffness to predict the progression of aortic aneurysm
Scientific Title:Acronym
The survey of the index of arterial sitffness to predict the progression of aortic aneurysm
Region
| Japan |
Condition
Condition
Aortic aneurysm
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To predict the pregression of abdominal aortic aneurysm
Basic objectives2
Others
Basic objectives -Others
To predict thorathic aortic aneurysm and aortic dissection
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The diagnosis of aortic aneurysm
Key secondary outcomes
Cardiovascular events
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 underwent CAVI or other vascular tests at outpatient clinic
Key exclusion criteria
Aortitis, other aortic disease
Target sample size
7000
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Masaki |
Organization
National Defense Medical College
Division name
Intensive Care Medicine
Zip code
359-8513
Address
3-2 Namiki, Tokorozawa,Saitama
TEL
+81429951211
masakinobuyuki@hotmail.com
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Masaki |
Organization
National Defense Medical College
Division name
Intensive Care Medicine
Zip code
359-8513
Address
3-2 Namiki, Tokorozawa,Saitama
TEL
+81429951211
Homepage URL
masakinobuyuki@hotmail.com
Sponsor or person
Institute
National Defense Medical College,Intensive Care Medicine
Institute
Department
Personal name
Funding Source
Organization
National Defense Medical College,Intensive Care Medicine
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Defense Medical College,Intensive Care Medicine
Address
3-2 Namiki, Tokorozawa,Saitama
Tel
+81429951211
masakinobuyuki@hotmail.com
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
| 2022 | Year | 03 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2030 | Year | 03 | Month | 01 | Day |
Other
Other related information
Other vascular physiological tests will be added if they seem promising.
Management information
Registered date
| 2022 | Year | 01 | Month | 06 | Day |
Last modified on
| 2023 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053120
