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

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 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


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

Value
https://center6.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