UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035643 |
|---|---|
| Receipt number | R000040601 |
| Scientific Title | Normality in T1mapping way Consideration of T1 value |
| Date of disclosure of the study information | 2019/01/23 |
| Last modified on | 2019/01/23 18:23:21 |
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Basic information
Public title
Normality in T1mapping way Consideration of T1 value
Acronym
Normality in T1mapping way Consideration of T1 value
Scientific Title
Normality in T1mapping way Consideration of T1 value
Scientific Title:Acronym
Normality in T1mapping way Consideration of T1 value
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of normal T1 value in T1mapping of the heart
Basic objectives2
Others
Basic objectives -Others
Not
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiac MRI images show myocardial T1,Measure the value
Key secondary outcomes
The difference in T1 prices by the gender and the heart rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
have a scan heart to MRI for healty subjects
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Male and female volunteers providing written informed consent not youger than 20 years old (at the time of informed consent)
Key exclusion criteria
Object with heart disease
Others who are deemed unsuitable for inclusion in the study for any other reason based on the assessment by the investigators
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kayoko Hirayama |
Organization
Kyusyu Medical Center
Division name
radiology department
Zip code
Address
1-8-1 jigyouhama cyuuou-ku, Hukuoka
TEL
092-852-0700
hirayama.kayoko.yu@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kayoko Hirayama |
Organization
Kyusyu Medical Center
Division name
radiology department
Zip code
Address
1-8-1 jigyouhama cyuuou-ku, Hukuoka
TEL
092-852-0700
Homepage URL
hirayama.kayoko.yu@mail.hosp.go.jp
Sponsor or person
Institute
Kyusyu Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2019 | Year | 01 | 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
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | 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
Management information
Registered date
| 2019 | Year | 01 | Month | 23 | Day |
Last modified on
| 2019 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040601
