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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031134
Receipt No. 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 2021/08/08

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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
Email 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
Email toshirok@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

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
Email 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 Partially published

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
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
2021 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035563

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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