UMIN-CTR Clinical Trial

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036810
Receipt No. 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 (Ver. 1)

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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
Last 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
Email anzai@med.hokudai.ac.jp

Public contact
1st 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
Email k-kamiya@med.hokudai.ac.jp

Sponsor
Institute Department of Cadiovascular Medicine, Hokkaido University Faculty of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041905