UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019716 |
|---|---|
| Receipt number | R000022766 |
| Scientific Title | Study for correlation between VO2 and survival ratio in elder patients with severe aortic stenosis after trance catheter aortic valve replacement.(Vista study). |
| Date of disclosure of the study information | 2015/11/10 |
| Last modified on | 2017/12/25 22:38:23 |
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Basic information
Public title
Study for correlation between VO2 and survival ratio in elder patients with severe aortic stenosis after trance catheter aortic valve replacement.(Vista study).
Acronym
Vista study
Scientific Title
Study for correlation between VO2 and survival ratio in elder patients with severe aortic stenosis after trance catheter aortic valve replacement.(Vista study).
Scientific Title:Acronym
Vista study
Region
| Japan |
Condition
Condition
Aortic Stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Correlation between peak VO2 and survival rate in patients with aortic stenosis after TAVR.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between peakVO2 and survival rate of 12 month after ATVR
Key secondary outcomes
Correlation among PeakVO2,VO2 at AT,PeakVO2/HR,minimum VE/VO2,VE vs VCO2 slope,delta VO2 WR,tau,peak/mean PG,max Velocity,AVA,AR,PVL,volume/grade,E/A,DcT,E/E dash and survival rate,re hospitalization, MACCE.
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
Patients with aortic stenosis after TAVR
Key exclusion criteria
Patients who can not be obtained the agreement form
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Murata Makoto |
Organization
Gunma Prefectual Cardiovascular Center
Division name
Division of Cardiology
Zip code
Address
3-12,Kameizumi-Kou,Maebashi-city,Gunma-ken,Japan
TEL
027-269-7455
yarukimanmann2000@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Murata Makoto |
Organization
Gunma prefectual cardiovascular center
Division name
Division of Cardiology
Zip code
Address
3-12,Kameizumi-Kou,Maebashi-city,Gunma-ken,Japan
TEL
027-269-7455
Homepage URL
yarukimanmann2000@yahoo.co.jp
Sponsor or person
Institute
Gunma prefectual cardiovascular center
Institute
Department
Personal name
Funding Source
Organization
Gunma prefectual cardiovascular center
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
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
群馬県立心臓血管センター
Gunma prefectual cardiovascular center
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 10 | 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
| 2015 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 01 | Month | 31 | Day |
Other
Other related information
We peforme Cardiopulmonary exercise test after TAVR to observe the survival rate after one year.
Management information
Registered date
| 2015 | Year | 11 | Month | 09 | Day |
Last modified on
| 2017 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022766
