UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024276
Receipt number R000027953
Scientific Title Feasibility of late iodine enhancement computed tomography (LIE-CT) for assessment of severity and prognosis of patients with myocardial infarction
Date of disclosure of the study information 2016/10/04
Last modified on 2016/10/04 08:13:27

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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


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

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 or person

Institute

Ehime University

Institute

Department

Personal name



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)



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

Value
https://center6.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