UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021663 |
|---|---|
| Receipt number | 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 13:50:58 |
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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
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
hoshide@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024978
| 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 |
