UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013735 |
|---|---|
| Receipt number | 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 11:32:34 |
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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
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
toshirok@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Hiroshima University Graduate School of Biomedical and Health Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014971
