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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023931
Receipt No. R000027557
Scientific Title Evaluation of values of myocardial T1 and T2 mapping
Date of disclosure of the study information 2016/09/12
Last modified on 2018/07/04

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Basic information
Public title Evaluation of values of myocardial T1 and T2 mapping
Acronym Values of myocardial T1 and T2 mapping
Scientific Title Evaluation of values of myocardial T1 and T2 mapping
Scientific Title:Acronym Values of myocardial T1 and T2 mapping
Region
Japan

Condition
Condition Cardiomyopathy
Classification by specialty
Cardiology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical values of T1 and T2 mapping
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Myocardial T1 and T2 values
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Measurement of myocaridial T1 and T2
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 The subject are patients who visited Keio University Hospital and whose cardiac MRI was ordered for evaluating cardiac disease. In addition, the written informed consent is indispensable for enrolling in this study.
Key exclusion criteria 1. Patients who is younger than 20 y/o
2. Patients during pregnancy or with suspicion of pregnancy
3. Patient who have implants which operate electrically, magnetically or mechanically (e.g. pacemaker)
4. Claustrophobia
Target sample size 100

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, Japan
TEL 03-3353-1211
Email shige@keio.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 shige@keio.jp

Sponsor
Institute Keio University School of Medicine
Department of Diagnostic Radiology
Institute
Department

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
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 09 Month 12 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
2016 Year 06 Month 14 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 12 Day
Last follow-up date
Date of closure to data entry
2018 Year 01 Month 01 Day
Date trial data considered complete
2018 Year 03 Month 01 Day
Date analysis concluded
2018 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2016 Year 09 Month 05 Day
Last modified on
2018 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027557

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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