UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027484 |
|---|---|
| Receipt number | R000031484 |
| Scientific Title | Late iodine enhancement computed tomography with image subtraction for assessment of myocardial infarction |
| Date of disclosure of the study information | 2017/07/31 |
| Last modified on | 2017/11/23 11:39:54 |
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Basic information
Public title
Late iodine enhancement computed tomography with image subtraction for assessment of myocardial infarction
Acronym
Feasibility of LIE-CT for assessment of myocardial infarction
Scientific Title
Late iodine enhancement computed tomography with image subtraction for assessment of myocardial infarction
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yuki Tanabe |
Organization
Ehime University
Division name
Radiology
Zip code
Address
Toon city, Ehime, Japan
TEL
089-960-5371
yuki.tanabe.0225@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Tanabe |
Organization
Ehime University
Division name
Radiology
Zip code
Address
Toon city, Ehime, Japan
TEL
089-960-5371
Homepage URL
yuki.tanabe.0225@gmail.com
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031484
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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