UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033321 |
|---|---|
| Receipt number | R000037125 |
| Scientific Title | Evaluation of relationship between cognitive function and frailty following TAVR (Transcatheter aortic valve replacement ) |
| Date of disclosure of the study information | 2018/07/07 |
| Last modified on | 2018/07/07 21:38:50 |
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Basic information
Public title
Evaluation of relationship between cognitive function and frailty following TAVR (Transcatheter aortic valve replacement )
Acronym
Evaluation of relationship between cognitive function and frailty following TAVR(Transcatheter aortic valve replacement )
Scientific Title
Evaluation of relationship between cognitive function and frailty following TAVR (Transcatheter aortic valve replacement )
Scientific Title:Acronym
Evaluation of relationship between cognitive function and frailty following TAVR(Transcatheter aortic valve replacement )
Region
| Japan |
Condition
Condition
Aortic valve stenosis
Classification by specialty
| Cardiology | Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate cognitive improvement before and after TAVR
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is evaluate association between cognitive improvement and frailty improvement after TAVR
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cognitive improvement following TAVR after short time period
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
| 60 | years-old | <= |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A patient who have cognitive dysfunction before TAVR
TAVR is planned for trans-femoral approach(TF approach)
Key exclusion criteria
A patients woh refused for evaluation cognitive function
A patients woh have severe cognitive dysfunction
A case of patient planned access route is except for trans-femoral approach
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kochi Yamane |
Organization
Yokkaichi Municipal hospital
Division name
Department of anesthesiology and critical care medicine
Zip code
Address
2-37 shibata 2-chome Yokkaichi-shi Mie 510-8567
TEL
059-354-1111
yamanekoken_com4@yokkaichihp01.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kochi Yamane |
Organization
Yokkaichi Municipal hospital
Division name
Department of anesthesiology and critical care medicine
Zip code
Address
2-37 shibata 2-chome Yokkaichi-shi Mie 510-8567
TEL
059-354-1111
Homepage URL
yamanekoken_com4@yokkaichihp01.jp
Sponsor or person
Institute
Yokkaichi Municipal hospital
Institute
Department
Personal name
Funding Source
Organization
Yokkaichi Municipal hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 07 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We evaluate cognitive function and frailty scale at preoperative,hospital discharge and first outpatient department after hospital discharge
We evaluate cognitive function using MMSE(Mini-Mental State Examination)and MOCA(Montral Cognitive Assesment).We score Frailty scale using Clinical Frailty Scale.
Management information
Registered date
| 2018 | Year | 07 | Month | 07 | Day |
Last modified on
| 2018 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037125
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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