UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033469 |
|---|---|
| Receipt number | R000038164 |
| Scientific Title | Measurement of peripheral pulse wave velocity measured by a novel pressure sensor |
| Date of disclosure of the study information | 2018/08/15 |
| Last modified on | 2022/01/24 08:49:47 |
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Basic information
Public title
Measurement of peripheral pulse wave velocity measured by a novel pressure sensor
Acronym
Measurement of peripheral pulse wave velocity measured by a novel pressure sensor
Scientific Title
Measurement of peripheral pulse wave velocity measured by a novel pressure sensor
Scientific Title:Acronym
Measurement of peripheral pulse wave velocity measured by a novel pressure sensor
Region
| Japan |
Condition
Condition
Cardiovascular diseases
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the measurement of peripheral pulse wave velocity (PWV) utilizing a novel pressure sensor, and compare it with conventional aortic PWV.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pulse wave velocity measured at carotid artery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients with cardiovascular diseases (hypertension and ischemic heart disease)
Interventions/Control_2
Healthy subjects
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
Patients who are treated in Tokyo Medical and Dental University medical hospital for cardiovascular diseases
Key exclusion criteria
Subjects who have an allergy to metal or surgical tape
Target sample size
96
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Sasano |
Organization
Tokyo Medical and Dental University
Division name
Department of Cardiovascular Physiology
Zip code
1138519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5365
sasano.bi@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuo |
| Middle name | |
| Last name | Sasano |
Organization
Tokyo Medical and Dental University
Division name
Department of Cardiovascular Physiology
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5365
Homepage URL
sasano.bi@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
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
Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel
03-5803-5096
syomu1.adm@tmd.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
| 2018 | Year | 08 | Month | 15 | 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
| 2018 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 21 | Day |
Last modified on
| 2022 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038164
