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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033321
Receipt No. R000037125
Official scientific title of the study 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

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Basic information
Official scientific title of the study Evaluation of relationship between cognitive function and frailty following TAVR (Transcatheter aortic valve replacement )
Title of the study (Brief title) 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 Kochi Yamane
Organization Yokkaichi Municipal hospital
Division name Department of anesthesiology and critical care medicine
Address 2-37 shibata 2-chome Yokkaichi-shi Mie 510-8567
TEL 059-354-1111
Email yamanekoken_com4@yokkaichihp01.jp

Public contact
Name of contact person Kochi Yamane
Organization Yokkaichi Municipal hospital
Division name Department of anesthesiology and critical care medicine
Address 2-37 shibata 2-chome Yokkaichi-shi Mie 510-8567
TEL 059-354-1111
Homepage URL
Email yamanekoken_com4@yokkaichihp01.jp

Sponsor
Institute Yokkaichi Municipal hospital
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 07 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037125

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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