Unique ID issued by UMIN | UMIN000044349 |
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Receipt number | R000049532 |
Scientific Title | Elucidation of the pathophysiology of artificial valve dysfunction after bioprosthetic valve replacement |
Date of disclosure of the study information | 2021/06/01 |
Last modified on | 2023/12/03 10:11:39 |
Elucidation of the pathophysiology of artificial valve dysfunction after bioprosthetic valve replacement
Elucidation of the pathophysiology of artificial valve dysfunction after bioprosthetic valve replacement
Elucidation of the pathophysiology of artificial valve dysfunction after bioprosthetic valve replacement
Elucidation of the pathophysiology of artificial valve dysfunction after bioprosthetic valve replacement
Japan |
structural valve deterioration after bioprosthetic valve replacement
Cardiovascular surgery |
Others
NO
Structural valve deterioration(SVD), such as progressive valve narrowing and leaflet tears, often occurs after bioprosthetic valve replacement, however the pathophysiology of SVD is still unknown. Recently, It is becoming clear that calcification of vessels or native aortic valve is formed through a process similar to bone formation.It is not clear whether a similar process is involved in the pathology of SVD, and the difference in SVD progression between the bioprosthetic valves used in SAVR and TAVR has not been studied. 18F-NaF positron emission tomography(PET) has been receiving great attention for imaging of tissue calcification including atherosclerosis. Herein we aim to analyze whether calcification is involved in the pathological condition of SVD and in what kind of patients it is easy to calcify by detecting calcified lesions by 18F-NaF PET, and to elucidate the pathophysiology of SVD.
Others
Elucidation of pathology
To assess whether there a correlation between the occurrence of svd after artificial valve replacement and the result of PET examination or not
To assess what patients are more likely to have SVD and whether there are differences in the type of valves used
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Other |
18F-NaF PET will be performed for patients after bioprosthetic valve replacement at our institute who have given informed consent. Standardized uptake value (SUV) max/mean of 18F on bioprosthetic valve and target-to-background ratio (TBR) max/mean, which is a ratio of 18F uptake on valve and right atrium(background), will be calculated and analyzed the correlation with SVD detected by TTE. The progression of SVD of the patients will be also carefully followed up after PET.
20 | years-old | <= |
Not applicable |
Male and Female
Patients who have undergone bioprosthetic valve replacement at our institutel and are following up
Age under 20 years old, cancer-bearing patients
80
1st name | Shigeru |
Middle name | |
Last name | Miyagawa |
Osaka University Graduate School of Medicine
Cardiovascular Surgery
565-0871
2-2, Yamadaoka, Suita, Osaka
06-6879-3154
sawa-p@surg1.med.osaka-u.ac.jp
1st name | Ai |
Middle name | |
Last name | Kawamura |
Osaka University Graduate School of Medicine
Cardiovascular Surgery
565-0871
2-2, Yamadaoka, Suita, Osaka
06-6879-3154
a-shibamoto@surg1.med.osaka-u.ac.jp
Osaka University Graduate School of Medicine, Cardiovascular Surgery
Self funding
Self funding
Osaka University Graduate School of Medicine, Cardiovascular Surgery
2-2, Yamadaoka, Suita, Osaka
06-6879-3154
a-shibamoto@surg1.med.osaka-u.ac.jp
NO
2021 | Year | 06 | Month | 01 | Day |
Unpublished
73
SAVR: n=51 (including 5 SVD patients)
TAVR: n=22
2021 | Year | 12 | Month | 07 | Day |
None
No longer recruiting
2021 | Year | 05 | Month | 27 | Day |
2021 | Year | 08 | Month | 10 | Day |
2021 | Year | 08 | Month | 11 | Day |
2026 | Year | 03 | Month | 31 | Day |
2021 | Year | 05 | Month | 27 | Day |
2023 | Year | 12 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049532
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