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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022854
Receipt No. R000026337
Scientific Title Impact of knowledge-based iterative model reconstruction on myocardial late iodine enhancement in computed tomography
Date of disclosure of the study information 2016/07/15
Last modified on 2017/05/20

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Basic information
Public title Impact of knowledge-based iterative model reconstruction on myocardial late iodine enhancement in computed tomography
Acronym Feasibility of late iodine enhancement CT with IMR
Scientific Title Impact of knowledge-based iterative model reconstruction on myocardial late iodine enhancement in computed tomography
Scientific Title:Acronym Feasibility of late iodine enhancement CT with IMR
Region
Japan

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

Objectives
Narrative objectives1 We evaluated the image quality and diagnostic performance of late iodine enhancement CT (LIE-CT) reconstructed with a knowledge-based iterative model reconstruction (IMR) for the detection of myocardial infarction (MI) assessed by late gadolinium enhancement magnetic resonance imaging (LGE-MRI) in comparison with filtered back projection (FBP) and hybrid iterative reconstruction (HIR).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Image quality score (visual score, signal to noise ratio, contrast to noise ratio)
Diagnostic performance for detecting MI (sensitivity, specificity, positive predictive value, negative predictive value)
Key secondary outcomes Image noise
CT attenuation difference between remote and infarcts myocardium
Reproducibility of diagnostic performance for detecting MI
Correlation in %MI volume between CT and MRI

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 (1) patients aged between 40 and 85 years
(2) clinically known or suspected of coronary artery disease
Key exclusion criteria (1) acute myocardial infarction
(2) cardiomyopathy
(3) severe left ventricular (LV) dysfunction (ejection fraction <20%)
(4) chronic atrial fibrillation
(5) greater than first degree atrioventricular block
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuki Tanabe
Organization Ehime University Graduate School of Medicine
Division name Department of Radiology
Zip code
Address Shitsukawa, Toon, Ehime, Japan
TEL 089-960-5371
Email yuki.tanabe.0225@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Tanabe
Organization Ehime University Graduate School of Medicine
Division name Department of Radiology
Zip code
Address Shitsukawa, Toon, Ehime, Japan
TEL 089-960-5371
Homepage URL
Email yuki.tanabe.0225@gmail.com

Sponsor
Institute Ehime University
Institute
Department

Funding Source
Organization Nothing
Organization
Division
Category of Funding Organization Other
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 07 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2013 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective study

Management information
Registered date
2016 Year 06 Month 23 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=R000026337

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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