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

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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 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


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

Value
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