UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023845 |
|---|---|
| Receipt number | R000027474 |
| Scientific Title | Real-world evaluation of Electrophysiological study; retrospective, cohort study |
| Date of disclosure of the study information | 2016/08/30 |
| Last modified on | 2023/03/06 10:55:00 |
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Basic information
Public title
Real-world evaluation of Electrophysiological study; retrospective, cohort study
Acronym
Real-world evaluation of Electrophysiological study; retrospective, cohort study
Scientific Title
Real-world evaluation of Electrophysiological study; retrospective, cohort study
Scientific Title:Acronym
Real-world evaluation of Electrophysiological study; retrospective, cohort study
Region
| Japan |
Condition
Condition
Supraventricular and ventricular arrhythmia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the current status and prognosis of patients undergoing cardiac electrophisiological study
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
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 electrophisiological study in Fukui University Hospital
Key exclusion criteria
Patients who do not give consent
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Tada |
Organization
University of Fukui Hospital
Division name
Department of Cardiovascular Medicine
Zip code
910-1193
Address
23-3, shimoaizuki, matsuoka, eiheiji-cho, yoshida-gun, Fukui, Japan
TEL
0776-61-3111
tmori@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuji |
| Middle name | |
| Last name | Morishita |
Organization
University of Fukui Hospital
Division name
Department of Cardiovascular Medicine
Zip code
910-1193
Address
23-3, shimoaizuki, matsuoka, eiheiji-cho, yoshida-gun, Fukui, Japan
TEL
0776-61-3111
Homepage URL
tmori@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui Hospital
Department of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
University of Fukui Hospital
Department of Cardiovascular Medicine
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
Medical Resaerch Support Center, University of Fukui Hospital
Address
23-3, shimoaizuki, matsuoka, eiheiji-cho, yoshida-gun, Fukui, Japan
Tel
0776-61-8529
tmori@u-fukui.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
| 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
| 2016 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 16 | 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
Retrospective Cohort Study
Management information
Registered date
| 2016 | Year | 08 | Month | 30 | Day |
Last modified on
| 2023 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027474
| 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 |
