UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047684 |
|---|---|
| Receipt number | 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 11:29:11 |
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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
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
k.hira884@outlook.jp
Sponsor or person
Institute
Division of nephrology and kidney center,
kobe university graduate school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054366
