UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052392 |
|---|---|
| Receipt number | R000059334 |
| Scientific Title | Studies to improve the detection rate of VHD in Japan - cardiology outpatient study - |
| Date of disclosure of the study information | 2023/10/03 |
| Last modified on | 2025/07/31 17:04:44 |
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Basic information
Public title
Studies to improve the detection rate of VHD in Japan - cardiology outpatient study -
Acronym
Studies to improve the detection rate of VHD in Japan - cardiology outpatient study -
Scientific Title
Studies to improve the detection rate of VHD in Japan - cardiology outpatient study -
Scientific Title:Acronym
Studies to improve the detection rate of VHD in Japan - cardiology outpatient study -
Region
| Japan |
Condition
Condition
Cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of visually represented cardiac murmurs and signs of heart conditions, visualized as images by the phonocardiograph, in screening for valvular heart disease and atrial fibrillation detection in real clinical settings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We calculate the accuracy rate of the detected cardiac murmurs and valvular heart disease (VHD) indicators from phonocardiograms* compared with the VHD diagnostic results based on echocardiography.
*AMI-SSS01 Series Phonocardiograph
Key secondary outcomes
We calculate the accuracy rate of the detected atrial fibrillation (AF) indicators from phonocardiograms* compared with the AF diagnostic results based on echocardiography.
*AMI-SSS01 Series Phonocardiograph
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Cardiology outpatients
2) 65 years or older
Key exclusion criteria
1) Patients with artificial heart valve implants
2) Patients with implanted cardiac pacemaker
3) Patients with congenital heart disease
Target sample size
270
Research contact person
Name of lead principal investigator
| 1st name | Kazuomi |
| Middle name | |
| Last name | Kario |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Medicine
Zip code
329-0498
Address
3311-1, Yakushiji, Shimotsuke, Tochigi
TEL
0285-58-7538
kkario@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Harada |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Medicine
Zip code
329-0498
Address
3311-1, Yakushiji, Shimotsuke, Tochigi
TEL
0285-44-2130
Homepage URL
harada.noriko@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Edwards Lifesciences Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hyogo Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University Hospital Bioethics Committee for Clinical Research
Address
3311-1, Yakushiji, Shimotsuke, Tochigi
Tel
0285-58-8933
rinri@jichi.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
自治医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 03 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Partially published
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
270
Results
A total of 266 individuals aged 65 years or older (mean age 74.6 years; 54.5% male) were included in the analysis. The sensitivity of phonocardiography for mild or more severe AS was 92.9%, and the specificity was 98.4%. The sensitivity of auscultation was 85.7%, and the specificity was 94.8% (p-value 0.36).
In the diagnosis of VHD, new phonocardiography provided relatively high sensitivity and specificity, especially for AS.
Results date posted
| 2025 | Year | 07 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Inclusion criteria:
1. Cardiology outpatients
2. 65 years or older
Exclusion criteria:
1. Patients with artificial heart valve implants
2. Patients with an implanted cardiac pacemaker
3. Patients with congenital heart disease
Participant flow
The subject will undergo an examination using the AMI-SSS01 Series Phonocardiograph, and a cardiac ultrasound examination will be performed on the same day.
Based on the results of the phonocardiogram test, a physician will make a diagnosis, compare it with the results of the echocardiogram test, and calculate the percentage of correct answers for the diagnosis of valvular heart disease.
Adverse events
None
Outcome measures
Primary outcomes:
Calculate the correct response rate of the phonocardiography test by comparing the number of valvular heart disease (VHD) diagnoses based on echocardiography to the number of heart murmurs and signs of VHD detected by the AMI-SSS01 Series Phonocardiograph.
Secondary outcomes:
Calculate the correct response rate of the phonocardiogram test by comparing the number of atrial fibrillation (AF) diagnoses based on echocardiography to the signs of AF detected by the AMI-SSS01 Series Phonocardiograph.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 29 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
1. The participants undergo both phonocardiograms* and echocardiography on the same day.
2. The results of VHD detection from the phonocardiograms are compared with the outcomes of echocardiography, and the accuracy rate is calculated.
3. The following information is collected from medical records:
1)Patient background (birthdate, date of visit, gender, medical history, underlying conditions, medications, self-reported symptoms)
2)Physical examination findings (height, weight, office blood pressure, auscultation findings)
3)Phonocardiogram findings, echocardiography findings
4. The following results are also collected from medical records if performed:
1)Electrocardiogram
2)CAVI (Cardio-Ankle Vascular Index) test
3)Hematological tests (hemoglobin level, red blood cell count)
4)Biochemical tests (AST, ALT, GGT, creatinine, blood glucose, LDL-C, HDL-C, TG, NT-proBNP)
5)Urinalysis (protein, glucose)
*AMI-SSS01 Series Phonocardiograph.
Management information
Registered date
| 2023 | Year | 10 | Month | 03 | Day |
Last modified on
| 2025 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059334
