UMIN-CTR Clinical Trial

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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017931
Receipt No. 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

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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
Institute Fujiidera Keijinkai Clinic
Institute
Department

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
URL(English) https://upload.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


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