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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018521
Receipt No. R000021436
Scientific Title The relationship between ECG-electrode placement and triggering cardiac cycle during high field MRI
Date of disclosure of the study information 2015/09/01
Last modified on 2019/09/07

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Basic information
Public title The relationship between ECG-electrode placement and triggering cardiac cycle during high field MRI
Acronym The relationship between ECG-electrode placement and triggering cardiac cycle during high field MRI
Scientific Title The relationship between ECG-electrode placement and triggering cardiac cycle during high field MRI
Scientific Title:Acronym The relationship between ECG-electrode placement and triggering cardiac cycle during high field MRI
Region
Japan

Condition
Condition Cardiac disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 improvement accuracy of triggering cardiac cycle during cardiac MRI
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ECG and MR image
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 healthy subjects.
during 2015.10 to 2015.12
electrocardiogram graph at inside and outside of MRI using 1.5T and 3.0T.
cardiac MRI(only CINE MRI) once per person.
Interventions/Control_2 The patients who were underwent a clinical cardiac MRI.
during 2015.5 to 2017.5.
electrocardiogram graph at inside and outside of MRI using 3.0T.
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 The study included randomly recruited healthy subjects who agree with our informed consent.
The patients who were underwent a clinical cardiac MRI with known or suspected cardiac disease.
Key exclusion criteria none
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kokubo Takashi
Organization Toranomon Hospital
Division name Department of Radiology
Zip code
Address 2-2-2 Toranomon, Minato-ku, Tokyo, Japan
TEL 03-3588-1111
Email sappukei85157@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Fukuzawa Kei
Organization Toranomon Hospital
Division name Department of Radiology
Zip code
Address 2-2-2 Toranomon, Minato-ku, Tokyo, Japan
TEL 03-3588-1111(2141)
Homepage URL
Email sappukei85157@gmail.com

Sponsor
Institute The relationship between ECG-electrode placement and triggering cardiac cycle during high field MRI
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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
2015 Year 09 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 Main results already published
Date of protocol fixation
2015 Year 08 Month 01 Day
Date of IRB
2015 Year 08 Month 15 Day
Anticipated trial start date
2015 Year 09 Month 01 Day
Last follow-up date
2020 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 02 Day
Last modified on
2019 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021436

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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