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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002350
Receipt No. 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

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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)
Email

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
Email

Sponsor
Institute Teikyo University Faculty of Medical Technology Department of Clinical Laboratory Science
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002843

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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