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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013735
Receipt No. R000014971
Scientific Title Clinical significance of coronary artery molecular imaging by 18F-labeled sodium fluoride positron emission tomography -comparison and combination with coronary computed tomography angiography
Date of disclosure of the study information 2014/04/17
Last modified on 2018/10/20

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Basic information
Public title Clinical significance of coronary artery molecular imaging by 18F-labeled sodium fluoride positron emission tomography
-comparison and combination with coronary computed tomography angiography
Acronym Coronary artery molecular imaging by NaF PET
Scientific Title Clinical significance of coronary artery molecular imaging by 18F-labeled sodium fluoride positron emission tomography
-comparison and combination with coronary computed tomography angiography
Scientific Title:Acronym Coronary artery molecular imaging by NaF PET
Region
Japan

Condition
Condition coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1) To describe the clinical significance of coronary artery molecular imaging by 18F-sodium fluoride PET, in relation to coronary calcium and plaque assessment on coronary CT
2) To elucidate the feasibility and usefulness of combination of coronary CT and 18-F NaF PET to detect high-risk patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1) Comparison with coronary CT findings (presence and characteristics of coronary calcium and mix or non-calcified coronary plaques) and 18-F NaF PET signal (presence and intensity)
2) potential of step-by-step approach using coronary CT and 18F-NaF PET to predict the cardiac hard events (cardiac death and acute coronary syndrome)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine Device,equipment
Interventions/Control_1 coronary CT, 18F-NaF PET
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 1) patients aged >= 30 years old
2) patients with clearly-distinguishable calcified and/or non-calcified and/or mixed coronary plaques on CT images of coronary arteries (diameter >=2-mm)
3) patients who agree with informed consent
Key exclusion criteria 1) acute coronary syndrome, critical heart failure
2) shock status
3) nonconciousness
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuki Kihara
Organization Hiroshima University Graduate School of Biomedical and Health Sciences
Division name Cardiovascular Medicine
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima City
TEL 082-257-5540
Email ykihara@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiro Kitagawa
Organization Hiroshima University Graduate School of Biomedical and Health Sciences
Division name Cardiovascular Medicine
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima City
TEL 082-257-5540
Homepage URL
Email toshirok@hiroshima-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Hiroshima University Graduate School of Biomedical and Health Sciences
Institute
Department

Funding Source
Organization Hiroshima University Graduate School of Biomedical and Health Sciences
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Hiroshima Heiwa Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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(広島県)

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ahajournals.org/doi/10.1161/JAHA.118.010224
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 Completed
Date of protocol fixation
2014 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 17 Day
Last follow-up date
2018 Year 07 Month 11 Day
Date of closure to data entry
2018 Year 07 Month 11 Day
Date trial data considered complete
2018 Year 07 Month 11 Day
Date analysis concluded
2018 Year 07 Month 11 Day

Other
Other related information

Management information
Registered date
2014 Year 04 Month 16 Day
Last modified on
2018 Year 10 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014971

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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