UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008657 |
|---|---|
| Receipt number | R000010172 |
| Scientific Title | Determination of the Accuracy of Three-Dimensional Cine Magnetic Resonance Imaging Using kat-ARC |
| Date of disclosure of the study information | 2012/09/15 |
| Last modified on | 2014/02/15 12:58:48 |
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Basic information
Public title
Determination of the Accuracy of Three-Dimensional Cine Magnetic Resonance Imaging Using kat-ARC
Acronym
Determination of the Accuracy of kat-ARC Cine MRI
Scientific Title
Determination of the Accuracy of Three-Dimensional Cine Magnetic Resonance Imaging Using kat-ARC
Scientific Title:Acronym
Determination of the Accuracy of kat-ARC Cine MRI
Region
| Japan |
Condition
Condition
Cardiac disease
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the accuracy of 3D kat-ARC cine MRI for the assessment of left ventricular functional analyses in comparison with 3D cine MRI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Interchangeability between the functional analyses results of 2D and 3D cine cardiac MRI
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who was ordered the cardiac MR examination including the left ventricular functional analysis.
Key exclusion criteria
1) Carrier of either pacemaker or defibrillator
2) Patients who cannot follow the operator's instruction, or hold his/her breath during image acquisition.
3) Claustrophobia
4) Patients who are younger than 18 years old
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeo Okuda |
Organization
Keio University School of Medicine
Division name
Department of Diagnostic Radiology
Zip code
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL
03-3352-1211
okuda@rad.med.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeo Okuda |
Organization
Keio University School of Medicine
Division name
Department of Diagnostic Radiology
Zip code
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
okuda@rad.med.keio.ac.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
GE Healthcare
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
USA
Other related organizations
Co-sponsor
GE Healthcare
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 15 | 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
Completed
Date of protocol fixation
| 2012 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 25 | Day |
Other
Other related information
This study is aimed to compare between 2D and 3D cine cardiac MRI. No other observations is required.
Management information
Registered date
| 2012 | Year | 08 | Month | 09 | Day |
Last modified on
| 2014 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010172
