UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024850 |
|---|---|
| Receipt number | 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 | 2020/05/19 16:06:31 |
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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 | Aoki |
| Middle name | |
| Last name | Atsushi |
Organization
Showa university
Division name
Cardiovascular surgery
Zip code
142-8555
Address
Tokyo Shinagawaku Hatanodai1-5-8
TEL
03-3784-8588
masudacvs@gmail.com
Public contact
Name of contact person
| 1st name | Masuda |
| Middle name | |
| Last name | Tomoaki |
Organization
Showa university
Division name
Cardiovascular surgery
Zip code
142-8555
Address
Tokyo Shinagawaku Hatanodai1-5-8
TEL
03-3784-8588
Homepage URL
gakuji@ofc.showa-u.ac.jp
Sponsor or person
Institute
Showa university
Institute
Department
Personal name
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
Showa university
Address
Tokyo Shinagawaku Hatanodai1-5-8
Tel
03-3784-8588
gakuji@ofc.showa-u.ac.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
| 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
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
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
| 2020 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028602
