UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036689 |
|---|---|
| Receipt number | R000041806 |
| Scientific Title | Evaluation of ambulatory blood pressure values measured by new wearable wrist-type blood pressure monitoring device |
| Date of disclosure of the study information | 2019/05/20 |
| Last modified on | 2020/04/03 14:40:12 |
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Basic information
Public title
Evaluation of ambulatory blood pressure values measured by new wearable wrist-type blood pressure monitoring device
Acronym
A study to evaluate the ambulatory blood pressure values measured by wearable monitoring device
Scientific Title
Evaluation of ambulatory blood pressure values measured by new wearable wrist-type blood pressure monitoring device
Scientific Title:Acronym
A study to evaluate the ambulatory blood pressure values measured by wearable monitoring device
Region
| Japan |
Condition
Condition
Patients with suspected or confirmed hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the ambulatory blood pressure values measured by wearable wrist-type blood pressure monitoring (WBPM) device and ambulatory blood pressure monitoring (ABPM) device
Basic objectives2
Others
Basic objectives -Others
Agreement
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean error and standard deviation of systolic blood pressure measured by WBPM and ABPM at the same measurement point
Key secondary outcomes
Mean error and standard deviation of diastolic blood pressure measured by WBPM and ABPM at the same measurement point
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Both of the ABPM device and the WBPM device are placed on non-dominant arm. Ambulatory blood pressure measurement with 30 minutes' interval for 24 hours are performed by ABPM. Patients are asked to measure blood pressure by WBPM (more than 10 times during 24 hours) just after ABPM interval measurement.
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) Patients who are scheduled to undergo ambulatory blood pressure monitoring in their clinical practice
2) wrist circumference: 16-19cm
3) Age => 20
Key exclusion criteria
Patients who are considered not eligible for the study by the investigators
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuomi |
| Middle name | |
| Last name | Kario |
Organization
Jichi Medical University School of Medicine
Division name
Division of cardiovascular medicine, Depertment of medicine
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, JAPAN
TEL
0285-58-7344
kkario@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Kazuomi |
| Middle name | |
| Last name | Kario |
Organization
Jichi Medical University School of Medicine
Division name
Division of cardiovascular medicine, Depertment of medicine
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, JAPAN
TEL
0285-58-7344
Homepage URL
kkario@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Sleep and Circadian Cardiology, Jichi Medical University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, JAPAN
Tel
0285-58-7344
kkario@jichi.ac.jp
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
| 2019 | Year | 05 | 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
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 09 | Day |
Last modified on
| 2020 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041806
| 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 |
