UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019503 |
|---|---|
| Receipt number | R000022548 |
| Scientific Title | Three-dimensional maximum principal strain using cardiac computed tomography for identification of myocardial infarction |
| Date of disclosure of the study information | 2015/11/23 |
| Last modified on | 2017/02/09 12:44:22 |
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Basic information
Public title
Three-dimensional maximum principal strain using cardiac computed tomography for identification of myocardial infarction
Acronym
Feasibility of maximum principal CT strain for identification of myocardial infarction
Scientific Title
Three-dimensional maximum principal strain using cardiac computed tomography for identification of myocardial infarction
Scientific Title:Acronym
Feasibility of maximum principal CT strain for identification of myocardial infarction
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to quantify the contractile function of the left ventricle (LV) with maximum principal strain, and to evaluate the diagnostic performance of this method for detecting myocardial infarction using late gadolinium enhancement-MRI as a gold standard.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy of left ventricular maximum principal strain for detecting myocardial infarction, compared with %systolic wall thickening.
Key secondary outcomes
Correlations between maximum principal strain and %systolic wall thickening / myocardial infarction volume.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent retrospective ECG-gated cardiac CT and comprehensive cardiac MRI within 14 days
Key exclusion criteria
(1) acute MI (<30 days), (2) cardiomyopathy, (3) severe LV dysfunction (ejection fraction <20%), (4) chronic atrial fibrillation, (5) greater than first degree atrioventricular block, (6) left complete bundle branch block, (7) valvular heart disease
Target sample size
40
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 City, Ehime
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 Graduate School of Medicine
Division name
Department of Radiology
Zip code
Address
Shitsukawa, Toon City, Ehime
TEL
089-960-5371
Homepage URL
yuki.tanabe.0225@gmail.com
Sponsor or person
Institute
Ehime University Graduate School of Medicine
Institute
Department
Personal name
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
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
| 2015 | Year | 11 | Month | 23 | 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 | 02 | 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
| 2015 | Year | 10 | Month | 26 | Day |
Last modified on
| 2017 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022548
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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