UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046448 |
|---|---|
| Receipt number | R000053000 |
| Scientific Title | Heart Sound Analysis Using Machine Learning in patients with Aortic Valve Stenosis |
| Date of disclosure of the study information | 2021/12/24 |
| Last modified on | 2025/01/13 12:56:13 |
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Basic information
Public title
Heart Sound Analysis Using Machine Learning in patients with Aortic Valve Stenosis
Acronym
Heart Sound Analysis Using Machine Learning in patients with Aortic Valve Stenosis
Scientific Title
Heart Sound Analysis Using Machine Learning in patients with Aortic Valve Stenosis
Scientific Title:Acronym
Heart Sound Analysis Using Machine Learning in patients with Aortic Valve Stenosis
Region
| Japan |
Condition
Condition
Aortic stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Diagnosis for severity of aortic stenosis by heart sound
Basic objectives2
Others
Basic objectives -Others
To build and algorithm for diagnosis of aortic stenosis severity using machine learning.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between the severity of AS estimated by deep learning and the severity of AS estimated by the Japanese Circulation Society Guidelines for the Treatment of Valvular Heart Disease, revised in 2020.
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
Male and Female
Key inclusion criteria
<AS group>
(1) Those who are 20 years old or older at the time of obtaining consent
(2) Those who have been diagnosed with aortic valve stenosis
3) Those who will undergo echocardiography.
(3) Those who do not refuse to participate in this study.
<Non-AS group>
1) Those who are 20 years old or older at the time of obtaining consent.
(2) Patients who have a systolic murmur, but aortic stenosis has been ruled out.
(3) Patients who do not refuse to participate in this study.
<Control group>
(1) Patients aged 20 years or older at the time of obtaining consent
(2) Those who do not have a systolic murmur
(3) Patients who will undergo echocardiography
3) Those who do not refuse to participate in this study.
Key exclusion criteria
<Common to all three groups>
(1) Those who refuse to cooperate in the research after disclosing the information using the opt-out method.
(2) Others who are judged by the principal investigator to be inappropriate as research subjects.
Target sample size
1100
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Nagai |
Organization
Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name
Department of Cardiovascular Medicine
Zip code
060-8638
Address
Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan
TEL
011-706-6973
nagai@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Miziguchi |
Organization
Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name
Department of Cardiovascular Medicine
Zip code
060-8638
Address
Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan
TEL
011-706-6973
Homepage URL
mizu-tay@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Non profit foundation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita-14 Nishi-5, Kita-ku, Sapporo, Hokkaido 060-8638, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2021 | Year | 12 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2030 | 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
| 2021 | Year | 12 | Month | 23 | Day |
Last modified on
| 2025 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053000
