UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Diagnostic performance of combined myocardial perfusion imaging and dual energy CT using 320-detector CT
Title of the study (Brief title)	Diagnostic performance of combined myocardial perfusion imaging and dual energy CT using 320-detector CT
Region	Japan

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

Objectives
Narrative objectives1	To detecte myocardial perfusion abnormalities at cardiac CT
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	myocardial perfusion abnormalities
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	Maneuver
Interventions/Control_1	Patients with coronary artery disease
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(a) Patients with coronary artery disease (b) Patients who are scheduled to perform SPECT or CAG (c) Age (40< year-old) (d) Patients given written informed consent
Key exclusion criteria	(a) Patients who had a previous allergic reaction to iodinated contrast material (b) Poor conditions (c) Asthma (d) Cerebral hemorrhage (e) Arrhythmia (f) Elevated serum creatinine level (g) Women who were potentially pregnant (h) Patients who are considered inappropriate for enrollement in this study
Target sample size	100

Research contact person
Name of lead principal investigator	Kazuo Awai
Organization	Hiroshima University
Division name	Diagnostic Radiology
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL	082-257-5257
Email	awai@hiroshima-u.ac.jp

Public contact
Name of contact person	Fuminari Tatsugami
Organization	Hiroshima University
Division name	Diagnostic Radiology
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL	082-257-5257
Homepage URL
Email	sa104@rg8.so-net.ne.jp

Sponsor
Institute	Department of Diagnostic Radiology, Hiroshima University
Institute
Department

Funding Source
Organization	Toshiba Medical
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	2013 Year 10 Month 29 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 06 Month 14 Day
Anticipated trial start date	2013 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 06 Month 30 Day

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

Management information
Registered date	2013 Year 10 Month 26 Day
Last modified on	2018 Year 07 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013332