UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029678 |
|---|---|
| Receipt number | R000033710 |
| Scientific Title | Diagnosis of arrhythmia using magnetocardiography |
| Date of disclosure of the study information | 2017/10/23 |
| Last modified on | 2017/10/23 20:03:45 |
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Basic information
Public title
Diagnosis of arrhythmia using magnetocardiography
Acronym
Diagnosis of arrhythmia using magnetocardiography
Scientific Title
Diagnosis of arrhythmia using magnetocardiography
Scientific Title:Acronym
Diagnosis of arrhythmia using magnetocardiography
Region
| Japan |
Condition
Condition
arrhythmia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish a method to evaluate the origin or mechanism of arrhythmia with minimal invasion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate whether cardiac magnetic field measurement of arrhythmia patients is effective
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
We take MRI images of heart at the same time measuring the magnetic field
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Healthy volunteers
No history of neurological disease in the past.(20-90 year old)
2.arrhythmia patients
Key exclusion criteria
1.Minors
2.The individuals who don't agree with the research
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuhiko Yagishita |
Organization
Tokyo Medical and Dental University
Division name
Department of Advanced Technology in Medicine
Zip code
Address
1-5-45 Yushima Bunkyo-ku Tokyo
TEL
03-5803-4195
atsuhikoyagishita.cvm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuhiko Yagishita |
Organization
Tokyo Medical and Dental University
Division name
Department of Advanced Technology in Medicine
Zip code
Address
1-5-45 Yushima Bunkyo-ku Tokyo
TEL
03-5803-4195
Homepage URL
atsuhikoyagishita.cvm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
RICOH COMPANY,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kanazawa Institute of Technology
Name of secondary funder(s)
TDK Corporation
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
| 2017 | Year | 10 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 11 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 23 | Day |
Last modified on
| 2017 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033710
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
