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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000047684
Receipt No. R000054366
Scientific Title An observational study about the association between ECG/UCG and cardiovascular disease in CKD
Date of disclosure of the study information 2022/05/09
Last modified on 2022/05/09

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Basic information
Public title An observational study about the association between ECG/UCG and cardiovascular disease in CKD
Acronym ECG and UCG for CVD in CKD
Scientific Title An observational study about the association between ECG/UCG and cardiovascular disease in CKD
Scientific Title:Acronym ECG and UCG for CVD in CKD
Region
Japan

Condition
Condition chronic kidney disease
Classification by specialty
Nephrology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the relationship between ECG/UCG and ischemic heart disease in advanced CKD
Basic objectives2 Others
Basic objectives -Others To investigate the relationship between ECG/UCG and the incidence of CVD and mortality
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Ischemic change for myocardial scintigraphy and exercise ECG
Key secondary outcomes any cause of death, CVD event, stroke event

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients who were admitted at Kobe University Hospital between January 2010 and December 2019
Key exclusion criteria insufficient clinical data
Target sample size 720

Research contact person
Name of lead principal investigator
1st name Hideki
Middle name
Last name Fujii
Organization kobe university graduate school of medicine
Division name Division of nephrology and kidney center
Zip code 650-0017
Address Kusunoki-cho, 7-5-2. chuo-ku, kobe city, hyogo pref
TEL 078-382-6500
Email fhideki@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Ken
Middle name
Last name Hirabayashi
Organization kobe university graduate school of medicine
Division name Division of nephrology and kidney center
Zip code 650-0017
Address Kusunoki-cho, 7-5-2. chuo-ku, kobe city, hyogo pref
TEL 078-382-6500
Homepage URL
Email k.hira884@outlook.jp

Sponsor
Institute Division of nephrology and kidney center,
kobe university graduate school of medicine
Institute
Department

Funding Source
Organization None
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 Kobe university clinical research ethical committee
Address Kusunoki-cho, chuo-ku, kobe city, hyogo pref
Tel 078-382-6669
Email cerb@med.kobe-u.ac.jp

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
2022 Year 05 Month 09 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 607
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 Completed
Date of protocol fixation
2020 Year 04 Month 01 Day
Date of IRB
2021 Year 05 Month 25 Day
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information retrospective observational study

Management information
Registered date
2022 Year 05 Month 09 Day
Last modified on
2022 Year 05 Month 09 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054366

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2022/05/10 Data.xlsx


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