UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Late iodine enhancement computed tomography with image subtraction for assessment of myocardial infarction
Title of the study (Brief title)	Feasibility of LIE-CT for assessment of myocardial infarction
Region	Japan

Condition
Condition	Myocardial infarction
Classification by specialty	Cardiology Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to evaluate the feasibility of image subtraction in late iodine enhancement computed tomography (LIE-CT) for assessment of myocardial infarction (MI) in comparison with MRI.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic performance of subtraction LIE-CT for detecting myocardial infarction (sensitivity, specificity, positive and negative predictive value). Assessment of transmurality extent of myocardial infarction with subtraction LIE-CT
Key secondary outcomes	Assessment of global extent of myocardial infarction with subtraction LIE-CT

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	Study population includes the patients who underwent cardiac CT and MRI suspected of coronary artery disease from March 2015 to May 2017.
Key exclusion criteria	Acute myocardial infarction Cardiomyopathy Chronic atrial fibrillation Severe cardiac dysfunction (EF<20%) Patients with other inappropriate factors for this study
Target sample size	30

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

Public contact
Name of contact person	Yuki Tanabe
Organization	Ehime University
Division name	Radiology
Address	Toon city, Ehime, Japan
TEL	089-960-5371
Homepage URL
Email	yuki.tanabe.0225@gmail.com

Sponsor
Institute	Ehime University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
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	2017 Year 07 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 01 Day
Anticipated trial start date	2015 Year 03 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	2017 Year 05 Month 25 Day
Last modified on	2017 Year 11 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031484