UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility of Peak Enhancement Ratio of Myocardium to Aorta for Identification of Myocardial Ischemia using Dynamic Myocardial Computed Tomography Perfusion Imaging
Title of the study (Brief title)	Feasibility of Peak Enhancement Ratio of Myocardium to Aorta for Identification of Myocardial Ischemia
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the feasibility of peak enhancement ratio of myocardium to aorta for identification of myocardial ischemia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of peak enhancement ratio of myocardium to aorta for the identification of myocardial ischemia
Key secondary outcomes	Correlation for peak enhancement values between myocardium and the ascending aorta

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent retrospective adenosine triphosphate (ATP)-loaded dynamic CTP and cardiac MRI within 30 days
Key exclusion criteria	(1) acute/old myocardial infarction (clinical information), (2) cardiomyopathy, (3) severe LV dysfunction (ejection fraction <20%), (4) chronic atrial fibrillation, (5) greater than first degree atrioventricular block, (6) left complete bundle branch block, (7) valvular heart disease, (8) history of percutaneous coronary intervention and coronary artery bypass graft, (9) patients having unrecognized myocardial infarction assessed by MR-late gadolinium enhancement (LGE).
Target sample size	40

Research contact person
Name of lead principal investigator	Yuki Tanabe
Organization	Ehime University Graduate School of Medicine
Division name	Department of Radiology
Address	Shitsukawa, Toon City, Ehime
TEL	089-960-5371
Email	yuki.tanabe.0225@gmail.com

Public contact
Name of contact person	Yuki Tanabe
Organization	Ehime University Graduate School of Medicine
Division name	Department of Radiology
Address	Shitsukawa, Toon City, Ehime
TEL	089-960-5371
Homepage URL
Email	yuki.tanabe.0225@gmail.com

Sponsor
Institute	Ehime University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Nothing
Organization
Division
Category of Funding Organization	Self funding
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	2015 Year 11 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 02 Month 01 Day
Anticipated trial start date	2011 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Retrospective study

Management information
Registered date	2015 Year 10 Month 27 Day
Last modified on	2017 Year 05 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022563