UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018232 |
|---|---|
| Receipt number | R000021106 |
| Scientific Title | Comparison of the evaluation by the three-dimensional phase contrast cine MRI and echocardiography after valve replacement surgery |
| Date of disclosure of the study information | 2015/07/10 |
| Last modified on | 2015/07/07 14:35:18 |
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Basic information
Public title
Comparison of the evaluation by the three-dimensional phase contrast cine MRI and echocardiography after valve replacement surgery
Acronym
Comparison of the evaluation by MRI and echocardiography after valve replacement
Scientific Title
Comparison of the evaluation by the three-dimensional phase contrast cine MRI and echocardiography after valve replacement surgery
Scientific Title:Acronym
Comparison of the evaluation by MRI and echocardiography after valve replacement
Region
| Japan |
Condition
Condition
Post aortic valve replacement procedure
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the equivalence between three dimensional cine MRI and echocardiography for postoperative evaluation of aortic valve replacement.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
effective orifice area of prosthetic valve
Key secondary outcomes
Pressure gradient of prosthetic valve
Left ventricular volume capacity
Cardiac mass
Changes in the blood flow direction of prosthetic valve
Pressure overload on the aortic wall
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
MRI
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 after aortic valve replacement
Key exclusion criteria
Patients which was used rare size of prosthetic valve
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoharu Nakano |
Organization
Tokyo Women's Medical University
Division name
Cardiovascular Surgery (Medical Center East)
Zip code
Address
Nishioku 2-1-10, Arakawa-ku, Tokyo, Japan
TEL
03-3810-1111
nakanoca@dnh.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Wataru Tatsuishi |
Organization
Tokyo Women's Medical University
Division name
Cardiovascular Surgery (Medical Center East)
Zip code
Address
Nishioku 2-1-10, Arakawa-ku, Tokyo, Japan
TEL
03-3810-1111
Homepage URL
wataru0812_drt@ybb.ne.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Scientific research fund
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
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
東京女子医科大学東医療センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 06 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 25 | 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
| 2015 | Year | 07 | Month | 07 | Day |
Last modified on
| 2015 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021106
