UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051608 |
|---|---|
| Receipt number | R000058698 |
| Scientific Title | Determination of reference values for cardiac magnetic resonance (CMR) T1/T2 mapping |
| Date of disclosure of the study information | 2023/07/20 |
| Last modified on | 2024/02/15 18:39:34 |
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Basic information
Public title
Determination of reference values for cardiac magnetic resonance (CMR) T1/T2 mapping
Acronym
Determination of reference values for cardiac magnetic resonance (CMR) T1/T2 mapping
Scientific Title
Determination of reference values for cardiac magnetic resonance (CMR) T1/T2 mapping
Scientific Title:Acronym
Determination of reference values for cardiac magnetic resonance (CMR) T1/T2 mapping
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the reference values T1 and T2 mapping with Cardiac MRI in National Institutes for Quantum Science and Technology (QST)
Basic objectives2
Others
Basic objectives -Others
Establish the reference values
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Establishment of reference values in more than a certain number of healthy adults
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Persons with the ability to give written consent to participate in this study
2) Men and women who are at least 20 years old and less than 70 years old at the time of consent, and who can hold their breath for 10 to 15 seconds
3) Persons who have been judged by a physician to be in good health
Key exclusion criteria
1) Those with a past or present history of serious physical or cardiac illness
2) Currently have an arrhythmia or HR of 90 or more or HR of 50 or less
3) Persons dependent on drugs or alcohol
4) Those with implanted medical devices(cardiac pacemaker, ICD, CRT, etc.) in the heart
5) Those with magnetic metals in the body (tattoos, intraocular lens , etc.) and claustrophobia
6) Pregnancy or possibility of being pregnant
7) High body weight (over 90 kg)
8) Those unable to hold their breath for 10 to 15 seconds
9) Persons deemed by the physician to be unsuitable for this examination
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Obata |
Organization
National Institutes for Quantum Science and Technology(QST)
Division name
Department of Molecular Imaging and Theranostics, Institute for Quantum Medical Science
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi 263-8555, Japan
TEL
043-206-3230
obata.takayuki@qst.go.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Obata |
Organization
National Institutes for Quantum Science and Technology(QST)
Division name
Department of Molecular Imaging and Theranostics, Institute for Quantum Medical Science
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi 263-8555, Japan
TEL
043-206-3230
Homepage URL
obata.takayuki@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology(QST)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Jichi Medical University Saitama Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes for Quantum Science and Technology Certified Review Board
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi 263-8555, Japan
Tel
043-206-4706
helsinki@qst.go.jp
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
| 2023 | Year | 07 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2023 | Year | 07 | Month | 14 | Day |
Last modified on
| 2024 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058698
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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