UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034917 |
|---|---|
| Receipt number | 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 01:36:28 |
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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
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
kfuku@med.kobe-u.ac.jp
Sponsor or person
Institute
Section of Arrhythmia, Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039585
