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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Terminated |
Unique ID issued by UMIN | UMIN000020322 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Normal volunteer Cardiomyopathy |
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Classification by specialty |
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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 |
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Interventions/Control_1 | T1 mapping imaging
Once during the diagnostic procedure of cardiac MRI |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) Normal Volunteer
2) Ideopathic cardiomyopathy 3) Secondary cardiomyophathy |
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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 |
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Target sample size | 25 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Iwate Medical University |
Institute | |
Department |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023175 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |