UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002239 |
|---|---|
| Receipt number | R000002742 |
| Scientific Title | the evaluation of ASO incidence rate in TOKUSHIMA |
| Date of disclosure of the study information | 2009/08/20 |
| Last modified on | 2010/01/23 11:26:09 |
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Basic information
Public title
the evaluation of ASO incidence rate in TOKUSHIMA
Acronym
EAIRT
Scientific Title
the evaluation of ASO incidence rate in TOKUSHIMA
Scientific Title:Acronym
EAIRT
Region
| Japan |
Condition
Condition
ASO, DM, Metabolic syndrome
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between ASO incidence and DM or metabolic syndrome.
Basic objectives2
Others
Basic objectives -Others
epidemiologic study
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
blood chemical analysis,height,body weight,ABI,echo
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
people from 20 to 60 years olds
Key exclusion criteria
none
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotsugu KUROBE |
Organization
the universuty of TOKUSHIMA Graduate of School
Division name
Department of Cardiovascular Surgery
Zip code
Address
3-18-15 Kuramoto-chou, TOKUSHIMA, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotsugu KUROBE |
Organization
the universuty of TOKUSHIMA Graduate of School
Division name
Department of Cardiovascular Surgery
Zip code
Address
3-18-15 Kuramoto-chou, TOKUSHIMA, JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Hrotsugu KUROBE
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Surgery, the university of TOKUSHIMA
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
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
| 2009 | Year | 08 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 01 | Day |
Other
Other related information
we will observe the cahnges of ABI, Age, Echography, blood test and body weight for 5 years
Management information
Registered date
| 2009 | Year | 07 | Month | 23 | Day |
Last modified on
| 2010 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002742
| 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 |
