UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009824 |
|---|---|
| Receipt number | R000011466 |
| Scientific Title | Correlation between retinal vessel diameter and blood pressure |
| Date of disclosure of the study information | 2013/01/21 |
| Last modified on | 2013/01/21 11:54:08 |
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Basic information
Public title
Correlation between retinal vessel diameter and blood pressure
Acronym
Correlation between retinal vessel diameter and blood pressure
Scientific Title
Correlation between retinal vessel diameter and blood pressure
Scientific Title:Acronym
Correlation between retinal vessel diameter and blood pressure
Region
| Japan |
Condition
Condition
Subjects who was consulted photographed fundus checkup at collaborating research institutes and Department of Ophthalmology Hokkaido University Hospital.
Classification by specialty
| Cardiology | Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the correlation between retinal vessel diameter and blood pressure using computer aided diagnosis system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation (systolic and diastolic) blood pressure and retinal vessel diameter.
Key secondary outcomes
To confirm the reproducibility of the computer-aided diagnosis system that automatically calculates retinal arteriovenous ratios.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Subjects fundus photographs were taken for medical checkup at collaborating research institutes and Department of Ophthalmology Hokkaido University Hospital from January 2013 to May 2013.
2. Subjects informed consent has been obtained for use of health checkup data in study.
Key exclusion criteria
1. Subjects available fundus photographs could not be obtained to analyze with poor imaging conditions.
2. Subjects research manager is deemed as unsuitable.
3. Subjects informed consent could not be obtained.
Target sample size
2467
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kousuke Noda |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
Nishi 7, Kita 15, Kita-ku, Sapporo 060-8638, Japan
TEL
+81-11-706-5944
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kousuke Noda |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
Nishi 7, Kita 15, Kita-ku, Sapporo 060-8638, Japan
TEL
+81-11-706-5944
Homepage URL
Sponsor or person
Institute
Department of Ophthalmology Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology Hokkaido University Graduate School of Medicine
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
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
北海道大学病院（北海道）、渓仁会円山クリニック
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 11 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2013 | Year | 01 | Month | 21 | Day |
Last modified on
| 2013 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011466
