UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024343 |
|---|---|
| Receipt number | R000027832 |
| Scientific Title | Imaging for Structural and Functional Changes of the Heart after Transcatheter Aortic Valve Implantation for Aortic Stenosis |
| Date of disclosure of the study information | 2016/10/08 |
| Last modified on | 2017/07/06 20:59:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Imaging for Structural and Functional Changes of the Heart after Transcatheter Aortic Valve Implantation for Aortic Stenosis
Acronym
Imaging-TAVI Study
Scientific Title
Imaging for Structural and Functional Changes of the Heart after Transcatheter Aortic Valve Implantation for Aortic Stenosis
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hiroaki Shimokawa |
Organization
Took University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574 Japan
TEL
+81-22-717-7153
shimo@cardio.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuharu Matsumoto |
Organization
Took University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574 Japan
TEL
+81-22-717-7153
Homepage URL
matsumoto@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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 | 08 | Month | 17 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027832
