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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048317
Receipt No. R000055062
Scientific Title infLuences of dIgital STEthoscope properties oN HEART sound analysis
Date of disclosure of the study information 2022/08/01
Last modified on 2022/07/25

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Basic information
Public title infLuences of dIgital STEthoscope properties oN HEART sound analysis
Acronym LISTEN-HEART
Scientific Title infLuences of dIgital STEthoscope properties oN HEART sound analysis
Scientific Title:Acronym LISTEN-HEART
Region
Japan

Condition
Condition Cardiovascular Diseases
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the influence of the difference in stethoscopes on the auscultation accuracy and on the AI development
Basic objectives2 Others
Basic objectives -Others To investigate the pathophysiologic difference
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes S III detection rate
Key secondary outcomes Performances of AIs developed from the sound recored by the different devices in diagnosing the severity of valvular heart disease and heart failure.

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 and Female
Key inclusion criteria (1) adult > 20 years old
(2) patients who underwent echocardiography
Key exclusion criteria (1) patients who cannot understand the study or mentally unstable
(2) patients who are considered inappropriate for the study by investigators
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Nobuyuki
Middle name
Last name Kagiyama
Organization Juntendo University
Division name Department of Cardiovascular Biology and Medicine
Zip code 1138421
Address 2-1-1 Hongo, Bunkyo-ku
TEL 0338133111
Email kagiyaman@juntendo.ac.jp

Public contact
Name of contact person
1st name Nobuyuki
Middle name
Last name Kagiyama
Organization Juntendo University
Division name Department of Cardiovascular Biology and Medicine
Zip code 1138421
Address 2-1-1 Hongo, Bunkyo-ku
TEL 0338133111
Homepage URL
Email kagiyaman@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

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

Other related organizations
Co-sponsor Tokushima University Hospital, Sakakibara Heart Institute, The Sakakibara Heart Institute of Okayama, National Cerebral and Cardiovascular Center, Nihon University Itabashi Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research Ethics Committee Faculty of Medicine, Juntendo University
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel 03-3813-3111
Email hongo-rinri@juntendo.ac.jp

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
2022 Year 08 Month 01 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
2022 Year 02 Month 19 Day
Date of IRB
Anticipated trial start date
2022 Year 08 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information nothing

Management information
Registered date
2022 Year 07 Month 08 Day
Last modified on
2022 Year 07 Month 25 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055062

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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