UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Imaging for Structural and Functional Changes of the Heart after Transcatheter Aortic Valve Implantation for Aortic Stenosis
Title of the study (Brief title)	Imaging-TAVI 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 structural and functional changes of the heart after Transcatheter aortic valve implantation for aortic stenosis
Basic objectives2	Others
Basic objectives -Others	Structural and functional changes of the heart after Transcatheter aortic valve implantation for aortic stenosis is assessed by perfusion CT and MRI
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(1)Myocardial blood flow measured by perfusion CT
Key secondary outcomes	(2)Myocardial hypertrophy,fibrosis and edema measured by MRI (3)General blood examination date,Rho-kinase activity (4)Remained angina (5)Ventricular function measured by cardiac echo (6)Left ventricular hypertrophy measured by ECG (7)Cognitive function measured by MMSE and Logical Memory (8)Leaflet thrombosis in bioprosthetic aortic valves (9)Mortality (10)Relationship between myocardial dysfunction and Rho-kinase

Base
Study type	Interventional

Study design
Basic design	expanded access
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Structural and functional changes of the heart is assessed by perfusion CT in three times
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	Patients who are applicate of transcatheter aortic valve implantation in aortic stenosis
Key exclusion criteria	(1)Coronary stenosis is over 50% (2)EF is under 50% (3)Severe renal failure (4)Severe adenosine allergy
Target sample size	50

Research contact person
Name of lead principal investigator	Hiroaki Shimokawa
Organization	Took 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	Took 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	2016 Year 10 Month 08 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 08 Month 17 Day
Anticipated trial start date	2016 Year 10 Month 08 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

Management information
Registered date	2016 Year 10 Month 08 Day
Last modified on	2017 Year 07 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027832