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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008657
Receipt No. 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

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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
Email 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
Email okuda@rad.med.keio.ac.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010172

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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