UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The feasibility study of a novel magnetocardiography
Title of the study (Brief title)	The feasibility study of a novel magnetocardiography
Region	Japan

Condition
Condition	healthy male
Classification by specialty	Cardiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Magnetocardiography is recorded by a novel magnetocardiography, and the feasibility and reproducibility of the wave of magnetocardiography is assessed.
Basic objectives2	Others
Basic objectives -Others	The visibility of P, Q, R, S, T wave recorded by a novel magnetocardiography are assessed.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The visibility of P, Q, R, S, T wave recorded by a novel magnetocardiography are assessed.
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	Not applicable
Gender	Male
Key inclusion criteria	healthy subject
Key exclusion criteria	1. past history of disease 2. past history of heart disease 3. subject joing the other study 4. not suitable for this study
Target sample size	25

Research contact person
Name of lead principal investigator	KOJI FUKUZAWA
Organization	Kobe University Graduate School of Medicine
Division name	Section of Arrhythmia, Division of Cardiovascular Medicine, Department of Internal Medicine
Address	Kusunoki-Cho 7-5-2, Chuoh-Ku, Kobe, Japan
TEL	078-382-5846
Email	kfuku@med.kobe-u.ac.jp

Public contact
Name of contact person	KOJI FUKUZAWA
Organization	Kobe University Graduate School of Medicine
Division name	Section of Arrhythmia, Division of Cardiovascular Medicine, Department of Internal Medicine
Address	Kusunoki-Cho 7-5-2, Chuoh-Ku, Kobe, Japan
TEL	078-382-5846
Homepage URL
Email	kfuku@med.kobe-u.ac.jp

Sponsor
Institute	Section of Arrhythmia, Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	ADVANTEST
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 07 Month 23 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 07 Month 23 Day
Anticipated trial start date	2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	none

Management information
Registered date	2018 Year 07 Month 23 Day
Last modified on	2018 Year 07 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038182