UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evidence for improved cognitive function following transcatheter aortic valve implantation in elderly patients with aortic stenosis - Brain perfusion SPECT imaging study-
Title of the study (Brief title)	Evidence for improved cognitive function following transcatheter aortic valve implantation in elderly patients with aortic stenosis - Brain perfusion SPECT imaging study-
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to investigate the relationship between cognitive function and cerebral blood flow after Transcatheter aortic valve implantation for aortic stenosis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	cerebral blood flow
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	aortic stenosis patients after Transcatheter aortic valve implantation
Key exclusion criteria	SPECT can not be analyzed
Target sample size	20

Research contact person
Name of lead principal investigator	Hiroaki Shimokawa
Organization	Tohoku University Hospital
Division name	Department of Cardiovascular Medicine
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574 Japan
TEL	+81-22-717-7153
Email	shimo@cardio.med.tohoku.ac.jp

Public contact
Name of contact person	Yasuharu Matsumoto
Organization	Tohoku University Hospital
Division name	Department of Cardiovascular Medicine
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574 Japan
TEL	+81-22-717-7153
Homepage URL
Email	matsumoto@cardio.med.tohoku.ac.jp

Sponsor
Institute	Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Mitsui Sumitomo Insurance Welfare Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
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 09 Month 19 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 09 Month 19 Day
Anticipated trial start date	2018 Year 09 Month 19 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	cerebral blood flow cognitive function

Management information
Registered date	2018 Year 09 Month 19 Day
Last modified on	2018 Year 09 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038994