UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016151 |
|---|---|
| Receipt number | R000018751 |
| Scientific Title | The diagnostic value of myocardial T1 mapping |
| Date of disclosure of the study information | 2015/01/07 |
| Last modified on | 2016/10/24 14:55:13 |
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Basic information
Public title
The diagnostic value of myocardial T1 mapping
Acronym
Myocardial T1 mapping
Scientific Title
The diagnostic value of myocardial T1 mapping
Scientific Title:Acronym
Myocardial T1 mapping
Region
| Japan |
Condition
Condition
Cradiomyopathy
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diagnostic value of T1 mapping obtained SMART1map.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Detection of pathological myocardial tissue by T1 mapping
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A person who has a cardiac MRI examination with an agreement to be enrolled in this study after obtaining informed consent
Key exclusion criteria
1. A person who is less than 20 years old
2. A person who is pregnant or suspected to be pregnant
3. A person who has any implant functioning electrically, magnetically or mechanically
4. Claustrophobia
5. Contraindication for the use of Gadolinium-based contrast material
Target sample size
30
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
Shinanomachi 35, Shinjyuku-ku, Tokyo, JAPAN
TEL
03-3225-5715
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
Shinanomachi 35, Shinjyuku-ku, Tokyo, JAPAN
TEL
03-3225-5715
Homepage URL
shige@keio.jp
Sponsor or person
Institute
Department of Diagnostic Radiology,
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Profit organization
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
慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2014 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 22 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 22 | Day |
Date trial data considered complete
| 2016 | Year | 10 | Month | 22 | Day |
Date analysis concluded
| 2016 | Year | 10 | Month | 24 | Day |
Other
Other related information
Using the cross-sectional method in which T1 map will be compared to LGE obtained in the same examination
Management information
Registered date
| 2015 | Year | 01 | Month | 07 | Day |
Last modified on
| 2016 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018751
