UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013617 |
|---|---|
| Receipt number | R000015510 |
| Scientific Title | Japan Prosthetic Valve Registry |
| Date of disclosure of the study information | 2014/04/07 |
| Last modified on | 2019/04/15 12:06:46 |
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Basic information
Public title
Japan Prosthetic Valve Registry
Acronym
J-PROVE Registry-Retro
Scientific Title
Japan Prosthetic Valve Registry
Scientific Title:Acronym
J-PROVE Registry-Retro
Region
| Japan |
Condition
Condition
post prosthetic valve replacement
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the outcome after prosthetic valve replacement in Japanese population.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
all cause death, cardiac death, cardiac event, cardiac function
Key secondary outcomes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Post aortic and/or mitral prosthetic valve replacement
Key exclusion criteria
patients without follow-up more than 5 years
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Chisato |
| Middle name | |
| Last name | Izumi |
Organization
Tenri Hospital
Division name
Department of Cardiology
Zip code
632-0015
Address
200 Mishima-cho, Tenri, Nara
TEL
0743-63-5611
izumi-ch@tenriyorozu.jp
Public contact
Name of contact person
| 1st name | Chisato |
| Middle name | |
| Last name | Izumi |
Organization
Tenri Hospital
Division name
Department of Cardiology
Zip code
632-0015
Address
200 Mishima-cho, Tenri, Nara
TEL
0743-63-5611
Homepage URL
izumi-ch@tenriyorozu.jp
Sponsor or person
Institute
Academic committee of Japanese society of Echocardiography
Institute
Department
Personal name
Funding Source
Organization
None
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
Tenri Hospital
Address
200Mishima-cho, Tenri
Tel
0743635611
izumi-ch@tenriyorozu.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
| 2014 | Year | 04 | Month | 07 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
late outcome after prosthetic valve replacement, retrospective
Management information
Registered date
| 2014 | Year | 04 | Month | 03 | Day |
Last modified on
| 2019 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015510
| 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 |
