UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031134 |
|---|---|
| Receipt number | R000035563 |
| Scientific Title | Clinical significance of 18F-Sodium Fluoride uptake for cardiovascular calcification on Positron Emission Tomography |
| Date of disclosure of the study information | 2018/02/04 |
| Last modified on | 2024/08/10 10:53:55 |
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Basic information
Public title
Clinical significance of 18F-Sodium Fluoride uptake for cardiovascular calcification on Positron Emission Tomography
Acronym
18F-Sodium Fluoride uptake for cardiovascular calcification
Scientific Title
Clinical significance of 18F-Sodium Fluoride uptake for cardiovascular calcification on Positron Emission Tomography
Scientific Title:Acronym
18F-Sodium Fluoride uptake for cardiovascular calcification
Region
| Japan |
Condition
Condition
Aortic valve calcification, Aortic stenosis, Coronary plaque
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate 18F-NaF uptake in cardiovascular calcification, especially in aortic valve and coronary plaque, in comparison with the findings of the other imaging modalities.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
We compare 18F-Sodium Fluoride uptake of aortic valve, coronary artery, carotid artery and aorta on Positron Emission Tomography with coronary CT findings of aortic valve calcification, coronary calcification, and non-calcified and partial calcified plaques (positive remodeling, low attenuation plaque, spotty calcification and napkin-ring sign).
Key secondary outcomes
We evaluate serial changes of aortic valve calcification on CT in 2-year period.
We classify 18F-NaF uptake pattern of aortic valve into three groups in relation to CT-based calcification; overlapping with calcification, adjacent to calcification and distant from calcification. Additionally, we evaluate the location of aortic valve calcification (valve leaflet or ring). We assess the progression of aortic valve calcification and aortic valve stenosis in relative to 18F-NaF uptake value and uptake pattern.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Combined PET/CT of the aortic valve and coronary plaque were performed within 1 month after cardiac CT imaging.
The patients were injected intravenously with a target dose of 185-370MBq 18F-NaF and rested in a quiet environment for 60 min. A non-enhanced CT scan for attenuation correction and a electrocardiogram-gated emission PET scan of the thorax were performed then.
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We include the patients with the following conditions.
1) Patients with coronary plaque (calcified plaque, non-calcified plaque and partial calcified plaque in >=2mm diameter coronary) or aortic valve calcification (CT value >=130HU) on coronary CT in Hiroshima University Hospital.
2) Patients over 30 years-old.
3) Patients without acute coronary syndromeand/or severe heart failure (within 3 months), or a unconscious condition.
4) Patients who agree with informed consent.
Key exclusion criteria
1) Patients with bad general conditions, for example, immediately after cerebral hemorrhage.
2) Pregnant and lactating females (include possibility of them).
3) Claustrophobic patients.
4) Patients who are judged unsuitable for this study by the person in charge.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Nakano |
Organization
Hiroshima University Graduate School of Biomedical and Health Sciences
Division name
Department of Cardiovascular Medicine
Zip code
734-8551
Address
Kasumi 1-2-3 Minami-ku, Hiroshima
TEL
082-257-5555
nakanoy@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiro |
| Middle name | |
| Last name | Kitagawa |
Organization
Hiroshima University Graduate School of Biomedical and Health Sciences
Division name
Department of Cardiovascular Medicine
Zip code
734-8551
Address
Kasumi 1-2-3 Minami-ku, Hiroshima
TEL
082-257-5555
Homepage URL
toshirok@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hiroshima Peace Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University hospital IRB
Address
Kasumi 1-2-3 Minami-ku, Hiroshima
Tel
082-257-5596
hugcp@hiroshima-u.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
広島大学病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
70
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
Main results already published
Date of protocol fixation
| 2017 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 04 | Day |
Last modified on
| 2024 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035563
