UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056402 |
|---|---|
| Receipt number | R000064435 |
| Scientific Title | Demonstration test for early detection of heart disease using a heart sound app |
| Date of disclosure of the study information | 2024/12/09 |
| Last modified on | 2025/12/23 13:27:30 |
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Basic information
Public title
Demonstration test for early detection of heart disease using a heart sound app
Acronym
Demonstration test for early detection of heart disease using a heart sound app
Scientific Title
Demonstration test for early detection of heart disease using a heart sound app
Scientific Title:Acronym
Demonstration test for early detection of heart disease using a heart sound app
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the relationship between data obtained from a heart sound app (made by Kokoromil) and underlying diseases or spontaneous stress levels
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Signs of atrial fibrillation, arrhythmia, and stress during the measurement period
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate
2.Persons who are 50 years old or more
Key exclusion criteria
1.Persons who were judged as inappropriate for study participants by the principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Okaniwa |
Organization
Kokoromil Co., Ltd.
Division name
Development Division
Zip code
160-0023
Address
Kanno Bld. 2F, 6-2-16, Nishi-shinjyuku,Shinjyuku-ku,, Tokyo, JAPAN
TEL
03-5323-0010
t-okaniwa@kokoromil.com
Public contact
Name of contact person
| 1st name | Shun |
| Middle name | |
| Last name | Yamada |
Organization
Kokoromil Co., Ltd.
Division name
Solutions Division
Zip code
160-0023
Address
Kanno Bld. 2F, 6-2-16,Nishi-shinjyuku,Shinjyuku-ku,, Tokyo, JAPAN
TEL
03-5323-0010
Homepage URL
s-yamada@kokoromil.com
Sponsor or person
Institute
Kokoromil Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kumamoto Prefectural Government
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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
| 2024 | Year | 12 | Month | 09 | 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
50
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
Completed
Date of protocol fixation
| 2024 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 12 | Month | 09 | Day |
Last modified on
| 2025 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064435
