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
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
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
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
