UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical significance of coronary artery molecular imaging by 18F-labeled sodium fluoride positron emission tomography -comparison and combination with coronary computed tomography angiography
Title of the study (Brief title)	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	Yasuki Kihara
Organization	Hiroshima University Graduate School of Biomedical and Health Sciences
Division name	Cardiovascular Medicine
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	Toshiro Kitagawa
Organization	Hiroshima University Graduate School of Biomedical and Health Sciences
Division name	Cardiovascular Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ahajournals.org/doi/10.1161/JAHA.118.010224
Results
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/icdr_e/ctr_view.cgi?recptno=R000014971