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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000021663
Receipt No. R000024978
Scientific Title Japan Beat-by-beat BP monitoring system development program
Date of disclosure of the study information 2016/04/01
Last modified on 2017/03/01

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Basic information
Public title Japan Beat-by-beat BP monitoring system development program
Acronym Japan Beat-by-beat BP monitoring system development program
(JBEAT-V1)
Scientific Title Japan Beat-by-beat BP monitoring system development program
Scientific Title:Acronym Japan Beat-by-beat BP monitoring system development program
(JBEAT-V1)
Region
Japan

Condition
Condition Cardiovascular disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the ability of two blood pressure monitoring methods to capture short-term blood pressure
Basic objectives2 Others
Basic objectives -Others Evaluation of blood pressure monitoring methods
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Agreement of blood pressure values measured by two methods
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 1) healthy volunteers
20 < age <50 years old
Subjects without cardiovascular diseases
baPWV < 1800

2) Patients
age > 50 years old
Subjects with cardiovascular disease
Patients whose blood pressure is stable by treatment
baPWV > 1800
Key exclusion criteria Age <20 years old
A between-arm difference measured by arm-cuff blood pressure monitor is > 20mmHg.
Patients judged to be unsuitable for participation for medical and the other reason : severe hypertension, AMI, unstable angina, heart failure, severe arrhythmia, blood flow disturbance, trauma, pregnant etc.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuomi Kario
Organization Jichi Medical University School of Medicine
Division name Division of Cardiovascular Medicine, Department of Medicine
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan
TEL 0285-58-7344
Email kkario@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Hoshide
Organization Jichi Medical University School of Medicine
Division name Division of Cardiovascular Medicine, Department of Medicine
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan
TEL 0285-58-7344
Homepage URL
Email hoshide@jichi.ac.jp

Sponsor
Institute Jichi Medical University School of Medicine
Institute
Department

Funding Source
Organization Omron Healthcare Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
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
2016 Year 04 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 Terminated
Date of protocol fixation
2016 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 04 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 To evaluate the agreement of blood pressure values during laboratory maneuvers that induced rapid and transient changes in blood pressure.

Management information
Registered date
2016 Year 03 Month 29 Day
Last modified on
2017 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024978

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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