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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045668
Receipt No. R000052131
Scientific Title Exploratory research for identifying change of brain parenchyma using MRI in patients following transcatheter aortic valve implantation
Date of disclosure of the study information 2021/10/11
Last modified on 2021/10/05

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Basic information
Public title Exploratory research for identifying change of brain parenchyma using MRI in patients following transcatheter aortic valve implantation
Acronym Exploratory research for identifying change of brain parenchyma using MRI in patients following transcatheter aortic valve implantation
Scientific Title Exploratory research for identifying change of brain parenchyma using MRI in patients following transcatheter aortic valve implantation
Scientific Title:Acronym Exploratory research for identifying change of brain parenchyma using MRI in patients following transcatheter aortic valve implantation
Region
Japan

Condition
Condition Aortic stenosis
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify change of brain parenchyma using MRI in patients following transcatheter aortic valve implantation
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes all-cause death
Key secondary outcomes cognitive function

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent transcatheter aortic valve implantation
Key exclusion criteria Patient refusal
Patients who cannot perform MRI examination
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Iwata
Organization Juntendo University
Division name Department of Cardiovascular Biology and Medicine
Zip code 113-8421
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3813-3111
Email hiroiwata-circ@juntendo.ac.jp

Public contact
Name of contact person
1st name Takuma
Middle name
Last name Koike
Organization Juntendo University
Division name Department of Cardiovascular Biology and Medicine
Zip code 113-8421
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 0338133111
Homepage URL
Email t-koike@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization none
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 Juntendo University
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel 0338133111
Email kenkyu5858@juntendo.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 順天堂大学医学部附属順天堂医院(東京都)

Other administrative information
Date of disclosure of the study information
2021 Year 10 Month 11 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
2021 Year 08 Month 16 Day
Date of IRB
2021 Year 08 Month 27 Day
Anticipated trial start date
2021 Year 10 Month 10 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Single center observational study

Management information
Registered date
2021 Year 10 Month 05 Day
Last modified on
2021 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052131

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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