UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036810 |
|---|---|
| Receipt number | R000041905 |
| Scientific Title | Study on postoperative prosthetic valve related complication prediction index by hemodynamics evaluation before and after aortic valve replacement in patients with severe aortic stenosis using time resolved 3D phase contrast MRI (4D flow MRI) |
| Date of disclosure of the study information | 2019/05/21 |
| Last modified on | 2019/05/21 16:26:00 |
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Basic information
Public title
Study on postoperative prosthetic valve related complication prediction index by hemodynamics evaluation before and after aortic valve replacement in patients with severe aortic stenosis using time resolved 3D phase contrast MRI (4D flow MRI)
Acronym
Study on postoperative prosthetic valve related complication prediction index by hemodynamics evaluation before and after aortic valve replacement in patients with severe aortic stenosis using time resolved 3D phase contrast MRI (4D flow MRI)
Scientific Title
Study on postoperative prosthetic valve related complication prediction index by hemodynamics evaluation before and after aortic valve replacement in patients with severe aortic stenosis using time resolved 3D phase contrast MRI (4D flow MRI)
Scientific Title:Acronym
Study on postoperative prosthetic valve related complication prediction index by hemodynamics evaluation before and after aortic valve replacement in patients with severe aortic stenosis using time resolved 3D phase contrast MRI (4D flow MRI)
Region
| Japan |
Condition
Condition
Aortic stenosis (AS)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our objective is to investigate the relationship between changes of blood flow velocity, blood flow pattern, wall shear stress, and energy loss measured by 4D Flow-MRI before and after transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) in patients with severe AS, and structural valve degeneration and leaflet thrombosis.
Basic objectives2
Others
Basic objectives -Others
identification of predictors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
to investigate the relationship between changes in blood flow dynamics (blood flow velocity, blood flow pattern, wall shear stress, energy loss) before and after TAVI or SAVR and structural valve degeneration and leaflet thrombosis
Key secondary outcomes
The prespecified secondary outcomes of the study are described below.
1. To compare changes in blood flow dynamics before and after TAVI or SAVR between TAVI and SAVR groups
2. To investigate factors associated with changes in blood flow dynamics before and after TAVI or SAVR
3. To investigate the relationship between changes in blood flow dynamics before and after TAVI or SAVR and the composite of structural valve degeneration, leaflet thrombosis, rehospitalization due to heart failure, and death
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed as severe AS in echocardiography and scheduled for TAVI or SAVR at Hokkaido University Hospital.
2. Patients 20 years of age and older are eligible.
3. All patients receive from physicians the information necessary to give informed consent in writing.
Key exclusion criteria
Exclusion criteria in patient's eligibility are described below.
1. Patients unsuitable for MRI
2. Patients judged to be inappropriate as research subjects by the researcher
Target sample size
315
Research contact person
Name of lead principal investigator
| 1st name | Toshihisa |
| Middle name | |
| Last name | Anzai |
Organization
Hokkaido University Faculty of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
060-8638
Address
Kita-15, Nishi-7, Kita-ku, Sapporo, Japan
TEL
011-706-6973
anzai@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Kiwamu |
| Middle name | |
| Last name | Kamiya |
Organization
Hokkaido University Faculty of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
060-8638
Address
Kita-15, Nishi-7, Kita-ku, Sapporo, Japan
TEL
011-706-6973
Homepage URL
k-kamiya@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Cadiovascular Medicine, Hokkaido University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital Division of Clinical Research Administration
Address
Kita-14, Nishi-5, Kita-ku, Sapporo, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 21 | 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
| 2019 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will prospectively perform this exploratory observational research. We will investigate the relationship between changes in blood flow dynamics (blood flow velocity, blood flow pattern, wall shear stress, energy loss) before and after TAVI or SAVR, and the following information.
1. Physical measurement
2. Laboratory data
3. Physiological function testing
4. Imaging tests, including echocardiography, coronary angiography, contrast-enhanced CT, and cardiovascular MRI
5. medications
6. structural valve degeneration and leaflet thrombosis
7. the composite of structural valve degeneration, leaflet thrombosis, rehospitalization due to heart failure, and death
And we will compare changes in blood flow dynamics before and after TAVI or SAVR between TAVI and SAVR groups.
Management information
Registered date
| 2019 | Year | 05 | Month | 21 | Day |
Last modified on
| 2019 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041905
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