UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036669 |
|---|---|
| Receipt number | R000041784 |
| Scientific Title | The impact of the degree of myocardial injury after transcatheter aortic valve implantation on left ventricle function after TAVI and predictors of myocardial injury after transcatheter aortic valve implantation |
| Date of disclosure of the study information | 2019/12/31 |
| Last modified on | 2019/05/07 22:33:14 |
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Basic information
Public title
The impact of the degree of myocardial injury after transcatheter aortic valve implantation on left ventricle function after TAVI and predictors of myocardial injury after transcatheter aortic valve implantation: SAPIEN 3 study
Acronym
The impact of the degree of myocardial injury after transcatheter aortic valve implantation on left ventricle function after TAVI and predictors of myocardial injury after transcatheter aortic valve implantation
Scientific Title
The impact of the degree of myocardial injury after transcatheter aortic valve implantation on left ventricle function after TAVI and predictors of myocardial injury after transcatheter aortic valve implantation
Scientific Title:Acronym
The impact of the degree of myocardial injury after transcatheter aortic valve implantation on left ventricle function after TAVI and predictors of myocardial injury after transcatheter aortic valve implantation
Region
| Japan |
Condition
Condition
aortic valve stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To aim to the impact of the degree of myocardial injury after transcatheter aortic valve implantation on left ventricle function after TAVI and predictors of myocardial injury after transcatheter aortic valve implantation
Basic objectives2
Others
Basic objectives -Others
To aim to the impact of the degree of myocardial injury after transcatheter aortic valve implantation on left ventricle function after TAVI and predictors of myocardial injury after transcatheter aortic valve implantation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The elevation in troponin T and recovery of 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
| 70 | years-old | <= |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) the presence of symptoms, 2) degenerative aortic stenosis with a New York Heart Association class II or higher, 3) an aortic-valve area < 1.0 cm2 (or an effective orifice area index < 0.6 cm2/m2) or mean pressure gradient >40 mmHg, 4) transfemoral (TF) approach, and 5) successful procedure
Key exclusion criteria
the use of dialysis
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Sato |
Organization
Tachikawa general hospital
Division name
Cardiology
Zip code
940-8621
Address
1-24 asahioka, Nagaoka city, Niigata prefecture Japan
TEL
0258-33-3111
kirotaro19731013@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Sato |
Organization
Tachikawa general hospital
Division name
Cardiology
Zip code
940-8621
Address
1-24 asahioka, Nagaoka city, Niigata prefecture Japan
TEL
0258-33-3111
Homepage URL
kirotaro19731013@yahoo.co.jp
Sponsor or person
Institute
Tachikawa general hospital
Institute
Department
Personal name
Funding Source
Organization
nothing to declare
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
Tachikawa general hospital
Address
1-24 asahioka, Nagaoka city, Niigata prefecture Japan
Tel
0258-33-3111
kirotaro19731013@yahoo.co.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
| 2019 | Year | 12 | Month | 31 | 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
68
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
| 2018 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2019 | Year | 05 | Month | 07 | Day |
Last modified on
| 2019 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041784
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
