UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002350 |
|---|---|
| Receipt number | R000002843 |
| Scientific Title | The study of the factor which exerts an error on the measurement of Cardio-Ankle Vascular Index (CAVI) |
| Date of disclosure of the study information | 2009/08/22 |
| Last modified on | 2010/02/18 10:54:52 |
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Basic information
Public title
The study of the factor which exerts an error on the measurement of Cardio-Ankle Vascular Index (CAVI)
Acronym
The study of the factor which exerts an error on the measurement of CAVI
Scientific Title
The study of the factor which exerts an error on the measurement of Cardio-Ankle Vascular Index (CAVI)
Scientific Title:Acronym
The study of the factor which exerts an error on the measurement of CAVI
Region
| Japan |
Condition
Condition
arteriosclerosis,
arteriosclerosis obliterans,
autonomic imbalance
Classification by specialty
| Medicine in general | Cardiology | Vascular surgery |
| Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
CAVI is reported as the inspection which undergoes an influence with blood pressure value hardly by extracting stiffness in the vein as the index of the new arteriosclerosis.
However, when implementing, are factual by the measure as CAVI value is judged to be a 40 year-old level, and so on, and it sometimes dissociated to level Ken usual youth of 20 years old.
It reviews by what factors such as the reproducibility of the inspection and the cold sake stimulation to the limb it exerts an error.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The showing indeed and which depends on being caused by unknown origin was sometimes reported.
The reliability of the measurement method rises if finding this cause and can contribute to the prevention of a lot of angiopathy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
The period: 2 optional days during April 1st in 2009 - December 31st
The number of times and the frequency: The cold sake stimulation of 20 minutes with once / the day, the ice water
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
| 24 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The man and woman from 20 healthy years old to 24 years old
Key exclusion criteria
The unhealthy man and woman
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akito Ohmura |
Organization
Teikyo University Faculty of Medical Technology
Division name
Department of Clinical Laboratory Science
Zip code
Address
2-11-1,Kaga,Itabasi-ku,Tokyo
TEL
03-3964-1211(2220)
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kaga |
Organization
Teikyo University Faculty of Medical Technology
Division name
Department of Clinical Laboratory Science
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Teikyo University Faculty of Medical Technology Department of Clinical Laboratory Science
Institute
Department
Personal name
Funding Source
Organization
None
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 | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2009 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 18 | Day |
Last modified on
| 2010 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002843
