UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Diagnostic performance of dual-energy coronary CT angiography for coronary artery stenosis using invasive coronary angiography as reference
Title of the study (Brief title)	Diagnostic performance of dual-energy coronary CT angiography for coronary artery stenosis using invasive coronary angiography as reference
Region	Japan

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

Objectives
Narrative objectives1	To compare the diagnostic performance of dual-energy coronary CT angiography (CCTA) with that of conventional single-energy CCTA for coronary artery stenosis using invasive coronary angiography as a gold standard.
Basic objectives2	Others
Basic objectives -Others	Diagnostic performance
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Coronary artery stenosis
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Conventional single-energy coronary CT angiography
Interventions/Control_2	Dual-energy coronary CT angiography
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Age equal to or more than 20 years 2. Scheduled to undergo a clinically indicated invasive coronary angiography (ICA) 3. underwent or agree to undergo coronary CT angiography with equal to or more than 64 multidetector row CT within 90 days before or after ICA 4. Heart rate at coronary CT andiography equal to or lower than 65 beats per minute
Key exclusion criteria	1. Prior coronary artery bypass graft (CABG) surgery 2. Contraindication to beta blocker agents, nitrates, or adenosine 3. Recent prior myocardial infarction 4. Prior pacemaker or internal defibrillator lead implantation 5. Tachycardia or significant arrhythmia 6. Impaired chronic renal function (serum creatinine >1.5 mg/dl) 7. Subjects with known anaphylactic allergy to iodinated contrast material 8. Pregnancy or unknown pregnancy status in subject of childbearing potential 9. Subject requires an emergent procedure
Target sample size	50

Research contact person
Name of lead principal investigator	Masahiro Jinzaki
Organization	Keio University School of Medicine
Division name	Department of Diagnostic Radiology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL	03-3353-1211(+81-3-3353-1211)
Email	jinzaki@rad.med.keio.ac.jp

Public contact
Name of contact person	Yoshitake Yamada
Organization	Keio University School of Medicine
Division name	Department of Diagnostic Radiology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL	03-3353-1211(+81-3-3353-1211)
Homepage URL
Email	yamada@rad.med.keio.ac.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	GE Healthcare
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 27 Day
Anticipated trial start date	2014 Year 07 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 05 Month 14 Day
Last modified on	2017 Year 08 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016227