UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility of Computed Tomography Derived Myocardial Blood Flow Using Whole-Heart Dynamic Computed Tomography Perfusion Imaging: Differentiation of Myocardial Ischemia and Infarction Assessed by Comparison with Cardiac Magnetic Resonance and Single Photon Emission Computed Tomography
Title of the study (Brief title)	Feasibility of CT-MBF for distinguishing among normal, ischemic and infarcted myocardium
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to evaluate the feasibility of myocardial blood flow (MBF) derived from whole-heart dynamic myocardial computed tomography perfusion (CTP) imaging using 256-slice multidetector-row computed tomography (256-slice MDCT) with adenosine triphosphate (ATP) stress in the detection of myocardial perfusion abnormalities (ischemia and infarction) on conventional myocardial perfusion imaging (SPECT and cardiac MR).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Differentiation of CT-derived MBF among normal, ischemic and infarcted myocardium in patient groups of SPECT and cardiac MR, respectively. Diagnostic accuracy of CT-derived MBF for detecting myocardial perfusion abnormality on SPECT and cardiac MR.
Key secondary outcomes

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	(1) Patients who give a full consent to this study (2) Effort or resting angina (chest pain, documented ST-T change on electrocardiogram [ECG], or symptoms relieved by administration of nitroglycerin) (3) Asymptomatic patients with multiple coronary risk factors for CAD. (4) All patients perform ATP-stree dynamic myocardial CT perfusion and myocardial perfusion imaging (SPECT or cardiac MRI) within a month.
Key exclusion criteria	(1) acute myocardial infarction (2) cardiomyopathy (3) severe left ventricular dysfunction (ejection fraction < 20%) (4) chronic atrial fibrillation (5) greater than first degree atrio-ventricular block (6) symptomatic congestive heart failure of New York Heart Association class IV (7)percutaneous coronary intervention (8) history of coronary artery bypass graft (9) hypotension (systolic blood pressure < 90 mm Hg) (10) severe chronic obstructive pulmonary disease (11) chronic kidney disease (serum creatinine > 1.5 mg/dl) (12) pregnancy (13) known history of hyperthyroidism and bronchial asthma (14) known hypersensitivity to contrast media.
Target sample size	50

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, Ehime, Japan
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, Ehime, Japan
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	None
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	2014 Year 12 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 04 Month 03 Day
Anticipated trial start date	2010 Year 05 Month 25 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	2014 Year 12 Month 16 Day
Last modified on	2017 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018219