UMIN-CTR Clinical Trial

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

Contact us.