UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility of late iodine enhancement computed tomography (LIE-CT) for assessment of severity and prognosis of patients with myocardial infarction
Acronym	Feasibility of LIE-CT for detecting MI
Scientific Title	Feasibility of late iodine enhancement computed tomography (LIE-CT) for assessment of severity and prognosis of patients with myocardial infarction
Scientific Title:Acronym	Feasibility of LIE-CT for detecting MI
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the feasibility of late iodine enhancement computed tomography (LIE-CT) for assessment of severity and prognosis of patients with myocardial infarction
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Prognostic value of LIE-CT findings: total mortality, cardiac death, acute myocardial infarction, admission with coronary artery disease, target vessel revascularization, target lesion revascularization
Key secondary outcomes	Feasibility of LIE-CT with ADMIRE in comparison with FBP and SAFIRE Comparison study between diastole and systole LIE-CT Feasibility ofLIE-CT with image subtraction technique of left ventricular cavity Feasibility of combined assessment of coronary CT angiography (CTA), myocardial CT perfusion (CTP), and LIE-CT in comparison with fractional flow reserve (FFR), and instantaneous wave-free ratio (iFR) Comparison study of coronary CTA, and myocardial CTP with quantitative coronary arteriography (QCA), FFR, and iFR Prognostic value of myocardial CTP findings: total mortality, cardiac death, acute myocardial infarction, admission with coronary artery disease, target vessel revascularization, target lesion revascularization

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
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Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with known/suspected coronary artery disease
Key exclusion criteria	Acute coronary syndrome, unstable angina, malignant arrhythmia, severe left ventricular dysfunction, aortic valve stenosis Old myocardial infarction Known allergic reaction to contrast media Known history of hyperthyroidism and bronchial asthma Chronic kidney disease Chronic atrial fibrillation Greater than first degree atrioventricular block, and sick sinus syndrome Patient with pacemaker and implantable cardioverter defibrillator Pregnancy Known allergic reaction to beta blocker
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yuki Tanabe
Organization	Ehime University Hospital School of Medicine
Division name	Radiology
Zip code
Address	Shitsukawa,Toon, Ehime
TEL	+81-89-960-5371
Email	yuki.tanabe.0225@gmai.com

Public contact
Name of contact person	1st name Middle name Last name Yuki Tanabe
Organization	Ehime University Hospital School of Medicine
Division name	Radiology
Zip code
Address	Shitsukawa,Toon, Ehime
TEL	+81-89-960-5371
Homepage URL
Email	yuki.tanabe.0225@gmai.com

Sponsor
Institute	Ehime University
Institute
Department

Funding Source
Organization	Nothing
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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IRB Contact (For public release)
Organization
Address
Tel
Email

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	2016 Year 10 Month 04 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2016 Year 10 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective study

Management information
Registered date	2016 Year 10 Month 04 Day
Last modified on	2016 Year 10 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027953

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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