UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056835 |
|---|---|
| Receipt number | R000060734 |
| Scientific Title | Morphological evaluation after aortic valve replacement using 4D Flow MRI |
| Date of disclosure of the study information | 2025/01/31 |
| Last modified on | 2025/01/27 15:05:41 |
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Basic information
Public title
Morphological evaluation after aortic valve replacement using 4D Flow MRI
Acronym
Morphological evaluation after aortic valve replacement using 4D Flow MRI
Scientific Title
Morphological evaluation after aortic valve replacement using 4D Flow MRI
Scientific Title:Acronym
Morphological evaluation after aortic valve replacement using 4D Flow MRI
Region
| Japan |
Condition
Condition
Aortic valve stenosis
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will use 4D Flow MRI to analyze and compare changes in blood flow dynamics in the aortic arch from the aortic valve before surgery, one week after surgery, and one year after surgery in the following groups: surgical bioprosthetic valve group, surgical mechanical valve group, and transcatheter aortic valve implantation low flow low gradient AS bioprosthetic valve group. We will also analyze patients with low flow low gradient severe aortic stenosis or suspected aortic valve dysfunction after aortic valve replacement using 4D Flow MRI to verify whether there are parameters that are characteristic of these conditions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoints: stroke volume, forward flow, backward flow, regurgitant fraction, ejection fraction, pressure gradient, streamlines flow from the aortic valve to the arch aorta, helical flow, vortical flow, blood velocity, energy loss, wall shear stress, and flow displacement. The primary endpoints: stroke volume, forward flow, backward flow, regurgitant fraction, ejection fraction, pressure gradient, and streamlines flow, helical flow, vortical flow, blood velocity, energy loss, wall shear stress, flow displacement, and the rate of change of these parameters with time in the aortic valve to the arch aorta.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Aortic valve stenosis
Key exclusion criteria
(1) When a patient requests to withdraw from participation in the study or withdraws consent
(2) When eligibility is found to be unsatisfactory after enrollment
(3) When adverse events make it difficult to continue the study
(4) When there is significant noncompliance
(5) When the entire study is discontinued
(6) When the physician deems it appropriate to terminate the study for any other reason (6) When the physician deems it appropriate to discontinue the study for other reasons.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Nakajima |
Organization
Sapporo Medical University
Division name
Cardiovascular surgery
Zip code
060-8543
Address
Sapporo City South 1 West 16
TEL
011-611-2111
t.nakajima@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Nakajima |
Organization
Sapporo Medical University
Division name
Cardiovascular surgery
Zip code
0608543
Address
Sapporo City South 1 West 16
TEL
011-611-2111
Homepage URL
t.nakajima@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University
Address
Sapporo City South 1 West 16
Tel
011-611-2111
t.nakajima@sapmed.ac.jp
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
| 2025 | Year | 01 | Month | 31 | 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
| 2023 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 01 | Month | 27 | Day |
Last modified on
| 2025 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060734
