UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049496 |
|---|---|
| Receipt number | R000056365 |
| Scientific Title | Regional disparities in the penetration of transvenous lead extraction for cardiac implantable electronic device infection: Insights from the national insurance claims database |
| Date of disclosure of the study information | 2022/11/14 |
| Last modified on | 2023/04/06 12:33:41 |
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Basic information
Public title
Regional disparities in the penetration of transvenous lead extraction for cardiac implantable electronic device infection: Insights from the national insurance claims database
Acronym
Regional disparities in the penetration of transvenous lead extraction for cardiac implantable electronic device infection: Insights from the national insurance claims database
Scientific Title
Regional disparities in the penetration of transvenous lead extraction for cardiac implantable electronic device infection: Insights from the national insurance claims database
Scientific Title:Acronym
Regional disparities in the penetration of transvenous lead extraction for cardiac implantable electronic device infection: Insights from the national insurance claims database
Region
| Japan |
Condition
Condition
Cardiac implantable electronic device (CIED) infection
Classification by specialty
| Cardiology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the penetration of transvenous lead extraction(TLE) for CIED infection in Japan and evaluate potential undertreatment using a nationwide insurance claims database.
Basic objectives2
Others
Basic objectives -Others
To describe regional disparities
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
the penetration of TLE for CIED infection between 2018 and 2020
Key secondary outcomes
Expected number of patients who underwent TLE for CIED infection between 2018 and 2020
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who underwent CIED implantation or generator exchange for two years between April 2018 and March 2020 in Japan
Key exclusion criteria
Surgery other than CIED and TLE
Target sample size
125448
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Isawa |
Organization
Sendai Kousei Hospital
Division name
Department of cardiology
Zip code
980-0873
Address
4-5 Hirose-machi, Aobaku, Sendai, Miyagi, Japan.
TEL
022-222-6181
isa_tsuyo@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Isawa |
Organization
Sendai Kousei Hospital
Division name
Department of cardiology
Zip code
980-0873
Address
4-5, Hirose-machi, Aobaku, Sendai, Miyagi, Japan
TEL
022-222-6181
Homepage URL
isa_tsuyo@yahoo.co.jp
Sponsor or person
Institute
Sendai Kousei Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Institutional Review Board on Sendai Kousei Hospital
Address
4-5, Hirose-machi, Aobaku, Sendai, Miyagi, Japan
Tel
022-222-6181
s.takahashi@sendai-kousei-hospital.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 | 11 | Month | 14 | 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
125448
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
| 2022 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We used NDB open data from April 2018 to March 2020.https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000177182.html(Access date; 14 November 2022.)
Management information
Registered date
| 2022 | Year | 11 | Month | 14 | Day |
Last modified on
| 2023 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056365
