UMIN-CTR Clinical Trial

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
Email	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
Email	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
Email

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
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

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