UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060490 |
|---|---|
| Receipt number | R000069191 |
| Scientific Title | Evaluation of the Diagnostic Utility of Pre-Echocardiographic Digital Auscultation: an open-label randomized controlled trial |
| Date of disclosure of the study information | 2026/01/27 |
| Last modified on | 2026/01/27 16:35:14 |
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Basic information
Public title
Evaluation of the Diagnostic Utility of Pre-Echocardiographic Digital Auscultation: an open-label randomized controlled trial
Acronym
Evaluation of the Diagnostic Utility of Pre-Echocardiographic Digital Auscultation
Scientific Title
Evaluation of the Diagnostic Utility of Pre-Echocardiographic Digital Auscultation: an open-label randomized controlled trial
Scientific Title:Acronym
Evaluation of the Diagnostic Utility of Pre-Echocardiographic Digital Auscultation
Region
| Japan |
Condition
Condition
valvular heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether use of the Super Stethoscope prior to echocardiography reduces diagnostic discrepancies in VHD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome was concordance between auscultation and echocardiographic findings, focusing on diagnostic discrepancies.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
the pre-echocardiography stethoscope
Interventions/Control_2
the post-echocardiography stethoscope
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who underwent echocardiography at Ultrasound Center in Kagawa University Hospital after being determined by a cardiologist or cardiovascular surgeon to require the test for suspecting cardiovascular disease.
Key exclusion criteria
Patients deemed unsuitable by the researcher
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | TAKAHISA |
| Middle name | |
| Last name | NOMA |
Organization
Faculty of Medicine, Kagawa University
Division name
Dept. of cardiorenal and cerebrovascular medicine
Zip code
761-0793
Address
1750-1, miki, kita, kagawa
TEL
087-898-5111
noma.takahisa.ps@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | takahisa |
| Middle name | |
| Last name | noma |
Organization
Faculty of Medicine, Kagawa university
Division name
Dept. of cardiorenal cerebrovascular medicine
Zip code
761-0793
Address
1750-1, miki, kita, kagawa
TEL
087-898-5111
Homepage URL
noma.takahisa.ps@kagawa-u.ac.jp
Sponsor or person
Institute
kagawa university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of Kagawa University Faculty of Medicine
Address
1750-1, miki, kita, kagawa
Tel
087-898-5111
kenkyushien-m@kagawa-u.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
| 2026 | Year | 01 | Month | 27 | 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
240
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 27 | Day |
Last modified on
| 2026 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069191
