UMIN-CTR Clinical Trial

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

healthy female volunteer

Classification by specialty

Cardiology

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

ADVANTEST

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

11

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

none

Registered date

2018

Year

11

Month

17

Day

Last modified on

2018

Year

11

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039585