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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024850
Receipt No. R000028602
Scientific Title A prospective, pre and post comparison, observational study for the improvement effect of cognitive function and ADL of post-TAVI
Date of disclosure of the study information 2016/11/16
Last modified on 2017/05/22

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Basic information
Public title A prospective, pre and post comparison, observational study for the improvement effect of cognitive function and ADL of post-TAVI
Acronym Cognitive function and ADL of post-TAVI
Scientific Title A prospective, pre and post comparison, observational study for the improvement effect of cognitive function and ADL of post-TAVI
Scientific Title:Acronym Cognitive function and ADL of post-TAVI
Region
Japan

Condition
Condition Aortic valve stenosis
Classification by specialty
Cardiology Neurology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine the improvement effect of cognitive function and cerebral blood flow before and after TAVI with cognitive function test and cerebral blood flow scintigraphy. In addition we examine the improvement effect of ADL.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The cognitive function test score(MMSE,HDS-R,FAB,MoCA-J,WMS-R)and the result of cerebral blood flow scintigraphy before and after TAVI.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The candidate patient of TAVI in our hospital
Key exclusion criteria Cerebral hemorrhage,brain tumor, hydrocephalus
Carotid stenosis
Central nervous system infection
Abnormal thyroid function
Poorly controlled glycemia
Drug addiction, Alcoholism
Hepatic encephalopathy
Mental disorder
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Aoki
Organization Showa university
Division name Cardiovascular surgery
Zip code
Address Tokyo Shinagawaku Hatanodai1-5-8
TEL 03-3784-8588
Email masudacvs@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tomoaki Masuda
Organization Showa university
Division name Cardiovascular surgery
Zip code
Address Tokyo Shinagawaku Hatanodai1-5-8
TEL 03-3784-8588
Homepage URL
Email gakuji@ofc.showa-u.ac.jp

Sponsor
Institute Showa university
Institute
Department

Funding Source
Organization Self-funding
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
Address
Tel
Email

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 11 Month 16 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 Open public recruiting
Date of protocol fixation
2016 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2016 Year 11 Month 15 Day
Last modified on
2017 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028602

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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