UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021425 |
|---|---|
| Receipt number | R000024004 |
| Scientific Title | Establishment of Clinical Significance using Magnetocardiography |
| Date of disclosure of the study information | 2016/03/30 |
| Last modified on | 2022/03/17 10:53:49 |
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Basic information
Public title
Establishment of Clinical Significance using Magnetocardiography
Acronym
Clinical study using Magnetocardiography
Scientific Title
Establishment of Clinical Significance using Magnetocardiography
Scientific Title:Acronym
Clinical study using Magnetocardiography
Region
| Japan |
Condition
Condition
heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine clinical utility of magnetocardiography
Basic objectives2
Others
Basic objectives -Others
clinical utility of magnetocardiography
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
evaluation of disease severity
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Organic heart disease
Key exclusion criteria
none
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kengo |
| Middle name | |
| Last name | Kusano |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular Medicine
Zip code
564-8565
Address
6-1 Kishibeshinmachi, Suita, Osaka, Japan
TEL
+81661701070
kusanokengo@hotmail.com
Public contact
Name of contact person
| 1st name | Kengo |
| Middle name | |
| Last name | Kusano |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular Medicine
Zip code
564-8565
Address
6-1 Kishibeshinmachi, Suita, Osaka, Japan
TEL
+81661701070
Homepage URL
kusanokengo@hotmail.com
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
National Cerebral and Cardiovascular Center
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
National Cerebral and Cardiovascular Center
Address
6-1 Kishibeshinmachi, Suita, Osaka, Japan
Tel
0661701070
kusanokengo@hotmail.com
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 | 03 | Month | 30 | 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
High-resolution magnetocardiography can predict later cardiac events in nonischemic cardiomyopathy with normal QRS duration.
Isolated late activation detected by magnetocardiography can predict future lethal arrhythmic event in pateints with arrhythmogenic right ventricular cardiomyopathy.Late potential from magnetocardiography is associated with cardiac events in patients with early repolarization syndrome.
Results date posted
| 2022 | Year | 03 | Month | 17 | Day |
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 | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | 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
Major Adverse Cardiac Events
Management information
Registered date
| 2016 | Year | 03 | Month | 10 | Day |
Last modified on
| 2022 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024004
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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