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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023847
Receipt No. R000027477
Scientific Title Retrospective analysis of cardiac implantable electronic device implantation
Date of disclosure of the study information 2016/08/30
Last modified on 2016/08/31

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Basic information
Public title Retrospective analysis of cardiac implantable electronic device implantation
Acronym Retrospective analysis of cardiac implantable electronic device implantation
Scientific Title Retrospective analysis of cardiac implantable electronic device implantation
Scientific Title:Acronym Retrospective analysis of cardiac implantable electronic device implantation
Region
Japan

Condition
Condition cardiac implantable electronic device implantation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of prognostic factor of patientsundergoing cardiac implantable electronic device implantation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Recurrence rate of supraventricular and ventricular arrhythmia.
Major adverse cardiac event (MACE), including cardiovascular death, non-fatal myocardial infarction, stroke, stent thrombosis, unstable angina and admission due to ischemic heart failure,implant of cardiovascular device, non--fatal arrhythmia,device infection
Key secondary outcomes all death, malignancy, worsening of renal function, onset of diabetes, hypertension and dyslipidemia.
Association with lipid profile, multimodalities and biomarkers.

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 undergo cardiac implantable electric device in Fukui University Hospital
Key exclusion criteria Patients who do not give consent
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Tada
Organization University of Fukui Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 23-3, shimoaizuki, matsuoka, eiheiji-cho, yoshida-gun, Fukui, Japan
TEL 0776-61-3111
Email htada2003@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuji Morishita
Organization University of Fukui Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 23-3, shimoaizuki, matsuoka, eiheiji-cho, yoshida-gun, Fukui, Japan
TEL 0776-61-3111
Homepage URL
Email tmori@u-fukui.ac.jp

Sponsor
Institute University of Fukui Hospital
Department of Cardiovascular Medicin
Institute
Department

Funding Source
Organization University of Fukui Hospital
Department of Cardiovascular Medicin
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
Address
Tel
Email

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
2016 Year 08 Month 30 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
2016 Year 08 Month 18 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective Cohort Study

Management information
Registered date
2016 Year 08 Month 30 Day
Last modified on
2016 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027477

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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