UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050504 |
|---|---|
| Receipt number | R000056100 |
| Scientific Title | The Accuracy of Artificial Intelligence (AI) in Diagnosing Arrhythmia |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/03/06 16:32:25 |
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Basic information
Public title
The Accuracy of Artificial Intelligence (AI) in Diagnosing Arrhythmia
Acronym
The Accuracy of Artificial Intelligence (AI) in Diagnosing Arrhythmia
Scientific Title
The Accuracy of Artificial Intelligence (AI) in Diagnosing Arrhythmia
Scientific Title:Acronym
The Accuracy of Artificial Intelligence (AI) in Diagnosing Arrhythmia
Region
| Japan |
Condition
Condition
Patients with an implanted Medtronic device (PM, ICD, CRT-P, CRT-D) who are being followed by remote monitoring.
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study whether AI can be used to accurately diagnose arrhythmic events captured by the device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Examine the degree of precision, recall, accuracy, and F-score rate of AI diagnosis for arrhythmias.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients on remote monitoring rigs with implanted Medtronic PMs, ICDs, CRTDs, and CRTPs.
Key exclusion criteria
Other than above
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ito |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357351
itomd@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Nishii |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name
Department of Cardiovascular Therapeutics
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357351
Homepage URL
nnishii@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Medtronic
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
Clinical Research Review Expert Committee, Department of Medical Sciences, Okayama University
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
Tel
086-235-6938
mae6605@adm.okayama-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
| 2023 | Year | 04 | Month | 01 | 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
| 2022 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2023 | Year | 03 | Month | 06 | Day |
Last modified on
| 2023 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056100
