UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042228 |
|---|---|
| Receipt number | 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 | 2024/01/04 12:51:43 |
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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
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
hkondo@oita-u.ac.jp
Sponsor or person
Institute
Department of Cardiology and Clinical Examination, Faculty of Medicine, Oita University
Institute
Department
Personal name
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
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
Enrolling by invitation
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
| 2030 | 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
| 2024 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048214
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
