UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048686 |
|---|---|
| Receipt number | R000055256 |
| Scientific Title | Relationship between ophthalmic examination information and automatic blood pressure monitor that can be measured at home |
| Date of disclosure of the study information | 2022/08/17 |
| Last modified on | 2024/03/29 16:27:29 |
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Basic information
Public title
Relationship between ophthalmic examination information and automatic blood pressure monitor that can be measured at home
Acronym
Relationship between ophthalmic examination information and automatic blood pressure monitor that can be measured at home
Scientific Title
Relationship between ophthalmic examination information and automatic blood pressure monitor that can be measured at home
Scientific Title:Acronym
Relationship between ophthalmic examination information and automatic blood pressure monitor that can be measured at home
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efforts to utilize in daily medical care, we aim to conduct research to investigate the relationship between home blood pressure and glaucoma.
Basic objectives2
Others
Basic objectives -Others
Relationship between home blood pressure and glaucoma
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Differences between patients with eye diseases and normal patients with parameters obtained by blood pressure monitors
Key secondary outcomes
Relationship between parameters acquired by blood pressure monitor and clinical / biological data
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Men and women between the ages of 20 and 75 who can decide whether or not to participate in the research on their own initiative.
Key exclusion criteria
Patients who do not have written consent
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Shigeto |
| Middle name | |
| Last name | Maekawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1Seiryo-machi,Aoba-ku, Sendai,Miyagi 980-8574,Japan
TEL
022-717-7294
smaekawa@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Shigeto |
| Middle name | |
| Last name | Maekawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1Seiryo-machi,Aoba-ku, Sendai,Miyagi 980-8574,Japan
TEL
022-717-7294
Homepage URL
smaekawa@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
OMRON HEALTHCARE Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Graduate School of Medicine Ethics Committee
Address
2-1Seiryo-machi,Aoba-ku, Sendai,Miyagi 980-8574,Japan
Tel
022-717-8007
ed-kenkyo@grp.tohoku.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
| 2022 | Year | 08 | Month | 17 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Factors: Fluctuations in home blood pressure
Results: Presence or absence of glaucoma, severity
Management information
Registered date
| 2022 | Year | 08 | Month | 17 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055256
