UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053259 |
|---|---|
| Receipt number | R000060539 |
| Scientific Title | Artificial Intelligence-based automated ECHOcardiographic measurements and the workflow of sonographers: Randomized Control Trial (AI-ECHO RCT) |
| Date of disclosure of the study information | 2024/01/10 |
| Last modified on | 2024/07/03 10:38:09 |
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Basic information
Public title
Artificial Intelligence-based automated ECHOcardiographic measurements and the workflow of sonographers: Randomized Control Trial (AI-ECHO RCT)
Acronym
Artificial Intelligence-based automated ECHOcardiographic measurements and the workflow of sonographers: Randomized Control Trial (AI-ECHO RCT)
Scientific Title
Artificial Intelligence-based automated ECHOcardiographic measurements and the workflow of sonographers: Randomized Control Trial (AI-ECHO RCT)
Scientific Title:Acronym
AI-ECHO RCT
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Medicine in general | Cardiology | Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether the use of AI-based automatic measurement increases the efficiency of echocardiography tests and the number of tests performed by sonographers.
Basic objectives2
Others
Basic objectives -Others
To determine whether the use of AI-based automatic measurement increases the efficiency of echocardiography tests and the number of tests performed by sonographers.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of echocardiographic tests performed one day and efficiency of tests.
Key secondary outcomes
Testing time per case; reporting time; changes in survey results; rate of change in measurements in final check by physician; and time required for final check by physician.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of AI-based automated echocardiographic measurements
Interventions/Control_2
Traditional manual measurements
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
The research subjects will be those who meet all of the following and do not meet any of the exclusion criteria.
(1) Clinical sonographers who are at least 20 years of age at the time of consent, who work full-time at Juntendo University Hospital, and who have at least one year of experience in echocardiography.
Key exclusion criteria
(1) Sonographers who are deemed by the physician in charge to have difficulty participating in the study due to reasons such as impaired comprehension or mental instability
(2)Sonographers who are deemed inappropriate for the study by the attending physician.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Tohru |
| Middle name | |
| Last name | Minamino |
Organization
Juntendo University Hospital
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
t.minamino@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Kagiyama |
Organization
Juntendo University Hospital
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
kagiyaman@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
M3 AI, Inc.
IRB Contact (For public release)
Organization
Medical Research Ethics Committee, Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3814-5672
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
順天堂大学医学部附属順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 10 | 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
8
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
| 2023 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2024 | 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
| 2024 | Year | 01 | Month | 02 | Day |
Last modified on
| 2024 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060539
