UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A feasibility study on the electrical activity measurement capability of a novel Magnetocardiography System healthy female volunteer
Title of the study (Brief title)	A feasibility study on the electrical activity measurement capability of a novel Magnetocardiography System healthy female volunteer
Region	Japan

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

Objectives
Narrative objectives1	We will try to acquire the magnetocardiogram in a healthy female volunteer by a novel magnetocardiography system. We hope to confirme that it is able to analyze the electrical activity of the heart by the magnetocardiogram. Furthermore, the correlation with the 12-lead electrocardiogram and the reproducibility of the magnetocardiogram are also investigated.
Basic objectives2	Others
Basic objectives -Others	The magnetocardiogram and standard 12Lead ECG are compared visually (morphology of P, Q, R, S and T wave). The association with the attenuation of magnetic field strength and female weight, height, chest circumference and BMI are also evaluated.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The magnetocardiogram and standard 12Lead ECG are compared visually (morphology of P, Q, R, S and T wave). The association with the attenuation of magnetic field strength and female weight, height, chest circumference and BMI are also evaluated.
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	Female
Key inclusion criteria	Healthy people who meet all the following criteria are eligible. 1. People get sufficient explanation about the purpose and contents of this study, the anticipated influence and danger by new medical equipment, and obtain the agreement. 2. Female and they aged 20 years or older at the time of agreement. 3. People who can obey the rules prescribed in the study, receive tests and have an examination, and can express subjective symptoms.
Key exclusion criteria	Healthy people correspond to even one of the following are excluded. 1. People who has health problems by history taking, auscultation, percussion, palpation and so on. 2. People participating in other clinical trials. 3. For other reasons Investigators and subinvestigator judged unsuitable as subjects of this trial.
Target sample size	5

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 11 Month 19 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 11 Month 19 Day
Anticipated trial start date	2019 Year 01 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 11 Month 17 Day
Last modified on	2018 Year 11 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039585