UMIN-CTR Clinical Trial

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
Email	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
Email	kusanokengo@hotmail.com

Sponsor
Institute	National Cerebral and Cardiovascular Center
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024004