UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017931
Receipt number R000020754
Scientific Title Development of the digital evaluation of Cardiothoracic ratio without the influence of breath
Date of disclosure of the study information 2015/06/17
Last modified on 2015/06/17 11:31:33

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Basic information

Public title

Development of the digital evaluation of Cardiothoracic ratio without the influence of breath

Acronym

Development of the digital evaluation of Cardiothoracic ratio without the influence of breath

Scientific Title

Development of the digital evaluation of Cardiothoracic ratio without the influence of breath

Scientific Title:Acronym

Development of the digital evaluation of Cardiothoracic ratio without the influence of breath

Region

Japan


Condition

Condition

End stage renal disease (ESRD) on Hemodialysis

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Our first purpose is to develop the digital evaluation of Cardiothoracic ratio (CTR) without the influence of breath among healthy adults. Second purpose is to validate this new CTR among hemodialysis patients.

Basic objectives2

Others

Basic objectives -Others

Development of new method

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Derivation study: Estimation of CTR by measuring inspiratory level
Validity study: Change of dry weight which three nephrologists diagnose

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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

80 years-old >

Gender

Male and Female

Key inclusion criteria

Development study:
Healthy adults who work at Fujiidera Keijinkai Clinic in June 2015.
Validation study:
Patients who receive hemodialysis at Fujiidera Keijinkai Clinic in December 2015.

Key exclusion criteria

Development study:
Participants who refuse to this study.
Validation study:
Patients who refuse to this study.
Patients who receive hemodialysis within 6-month.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takayuki Myose

Organization

Fujiidera Keijinkai Clinic

Division name

Department of radiology

Zip code


Address

1-2-3 Emisaka Fujiidera City, Osaka, 583-0036, Japan

TEL

072-930-0222

Email

myose@e-touseki.net


Public contact

Name of contact person

1st name
Middle name
Last name Takayuki Myose

Organization

Fujiidera Keijinkai Clinic

Division name

Department of radiology

Zip code


Address

1-2-3 Emisaka Fujiidera City, Osaka, 583-0036, Japan

TEL

072-930-0222

Homepage URL


Email

myose@e-touseki.net


Sponsor or person

Institute

Fujiidera Keijinkai Clinic

Institute

Department

Personal name



Funding Source

Organization

Osaka Society for Dialysis Therapy

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


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



Other administrative information

Date of disclosure of the study information

2015 Year 06 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

Enrolling by invitation

Date of protocol fixation

2015 Year 05 Month 18 Day

Date of IRB


Anticipated trial start date

2015 Year 06 Month 17 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Development study:
The prospective study, sequence sampling.
<Methods>
Chest X-rays, including the maximum inspiratory phase, the maximum expiratory phase, two-thirds and one-third inspiratory phase, are performed at the same time. We measure the area of thorax and CTR from these X-rays. We estimate e-CTR, which is supposed at the maximum inspiratory phase at the maximum expiratory phase, two-thirds and one-third inspiratory phase.

Validation study:
The retrospective study, random sampling.
<Methods>
We estimated e-CTR among hemodialysis patients by using above estimation. We randomly choose 2 X-rays from same patients and calculate the difference of e-CTR. We divide couples of X-rays by the difference of e-CTR. The difference of e-CTR in one group is above 5%. On the other hand, the difference of e-CTR in another group is under 5%. Two nephrologists, who are blinded to the groups, decide whether to up or down by the only image of X-rays.


Management information

Registered date

2015 Year 06 Month 16 Day

Last modified on

2015 Year 06 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020754


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name