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

Email



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


Email



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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name