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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034917
Receipt No. R000039585
Scientific Title A feasibility study on the electrical activity measurement capability of a novel Magnetocardiography System healthy female volunteer
Date of disclosure of the study information 2018/11/19
Last modified on 2018/11/17

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Basic information
Public title A feasibility study on the electrical activity measurement capability of a novel Magnetocardiography System healthy female volunteer
Acronym A feasibility study on the electrical activity measurement capability of a novel Magnetocardiography System healthy female volunteer
Scientific Title A feasibility study on the electrical activity measurement capability of a novel Magnetocardiography System healthy female volunteer
Scientific Title:Acronym 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
1st name
Middle name
Last name KOJI FUKUZAWA
Organization Kobe University Graduate School of Medicine
Division name Section of Arrhythmia, Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
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
1st name
Middle name
Last name KOJI FUKUZAWA
Organization Kobe University Graduate School of Medicine
Division name Section of Arrhythmia, Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

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 Preinitiation
Date of protocol fixation
2018 Year 11 Month 19 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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