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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042228
Receipt No. R000048214
Scientific Title Analysis of Adipose Tissue Profile and Prognosis in patients with CIED
Date of disclosure of the study information 2020/10/25
Last modified on 2020/10/25

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Basic information
Public title Analysis of Adipose Tissue Profile and Prognosis in Patients with CIED
Acronym Analysis of Adipose Tissue Profile and Prognosis in patients with CIED
Scientific Title Analysis of Adipose Tissue Profile and Prognosis in patients with CIED
Scientific Title:Acronym Analysis of Adipose Tissue Profile and Prognosis in patients with CIED
Region
Japan

Condition
Condition Bradyarrhythmia(Sick Sinus Syndrome, Atrio-Ventricular Block)
Tachyarrhythmia
Atrial Tachycardia
Atrial Fibrillation
Ventricular Tachycardia
Ventricular Fibrillation
Chronic Heart Failure
Cardiomyopathy
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To investigate the prognostic value of endocrine effect derived from subcutaneous adipose tissue in patients with cardiac implantable electronic devices (CIED)
Basic objectives2 Others
Basic objectives -Others To investigate the prognostic value of endocrine effect derived from subcutaneous adipose tissue in patients with cardiac implantable electronic devices (CIED)
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hospitalization due to heart failure, Stroke, Cardiovasculat death, all cause mortality
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients who are going to undergo implantation or replacement of CIED.
Key exclusion criteria Severe systemic infection, dysfunction of liver and kidney, cerebrovascular disease
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Naohiko
Middle name
Last name Takahashi
Organization Oita University
Division name Faculty of Medicine
Zip code 879-5593
Address 1-1 idaigaoka Hasama-machi, Yufu, Oita
TEL 0975866166
Email takanao@oita-u.ac.jp

Public contact
Name of contact person
1st name Hidekazu
Middle name
Last name Kondo
Organization Oita University
Division name Faculty of Medicine
Zip code 879-5593
Address 1-1 idaigaoka Hasama-machi, Yufu, Oita
TEL 0975866166
Homepage URL
Email hkondo@oita-u.ac.jp

Sponsor
Institute Department of Cardiology and Clinical Examination, Faculty of Medicine, Oita University
Institute
Department

Funding Source
Organization Department of Cardiology and Clinical Examination, Faculty of Medicine, Oita University
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 Faculty of Medicine, Oita University
Address 1-1 idaigaoka Hasama-machi, Yufu, Oita
Tel 0975866166
Email takanao@oita-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
2020 Year 10 Month 25 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 Open public recruiting
Date of protocol fixation
2020 Year 06 Month 22 Day
Date of IRB
2020 Year 06 Month 22 Day
Anticipated trial start date
2020 Year 06 Month 22 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Nothing to report

Management information
Registered date
2020 Year 10 Month 25 Day
Last modified on
2020 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048214

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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