UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020322 |
|---|---|
| Receipt number | R000023175 |
| Scientific Title | Feasibility of myocardial T1 mapping using 1.5T MRI in comparison with 3T MRI |
| Date of disclosure of the study information | 2016/02/01 |
| Last modified on | 2018/06/26 09:41:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Feasibility of myocardial T1 mapping using 1.5T MRI in comparison with 3T MRI
Acronym
Feasibility study of 1.5T myocardial T1 mapping
Scientific Title
Feasibility of myocardial T1 mapping using 1.5T MRI in comparison with 3T MRI
Scientific Title:Acronym
Feasibility study of 1.5T myocardial T1 mapping
Region
| Japan |
Condition
Condition
Normal volunteer
Cardiomyopathy
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the feasibility of T1 mapping imaging by 1.5T MRI
Basic objectives2
Others
Basic objectives -Others
Feasibility study of T1 mapping imaging by 1.5T MRI
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Estimation of T1 mapping imaging between 1.5T MRI in normal volunteer
2) Assessment of lesion detectability in typical cardiomyopathy
3) Assessment of appearence in cases of non-ideopathic cardiomyopathy
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
T1 mapping imaging
Once during the diagnostic procedure of cardiac MRI
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
1) Normal Volunteer
2) Ideopathic cardiomyopathy
3) Secondary cardiomyophathy
Key exclusion criteria
1) Under 19 years old
2) Unavailability in obtaining of consensus
3) Patients who cannot maintain supine position more than 30 minutes
4) Patients who cannot hold their breath
5) Patients with severe arrhythmic complication
6) Patients with severe anemia
7) Patients with renal impairment (eGFR < ml/min./1.73m^2
8) Patients who are considered unsuitable for recluit
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryoichi Tanaka |
Organization
Iwate Medical University
Division name
Radiology
Zip code
Address
19-1 Uchimaru Morioka-shi, Iwate
TEL
019-651-5111
rtanaka@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoichi Tanaka |
Organization
Iwate Medical University
Division name
Radiology
Zip code
Address
19-1 Uchimaru Morioka-shi, Iwate
TEL
019-651-5111
Homepage URL
rtanaka@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Iwate Medical university
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
| 2016 | Year | 02 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 12 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 24 | Day |
Last modified on
| 2018 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023175
