UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061040 |
|---|---|
| Receipt number | R000069560 |
| Scientific Title | Validation of atrial fibrillation screening strategies in patients with ischemic heart disease using artificial intelligence electrocardiography (CVI ARO 21 Study) |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/24 16:55:31 |
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Basic information
Public title
Validation of atrial fibrillation screening strategies in patients with ischemic heart disease using artificial intelligence electrocardiography (CVI ARO 21 Study)
Acronym
Validation of atrial fibrillation screening strategies in patients with ischemic heart disease using artificial intelligence electrocardiography (CVI ARO 21 Study)
Scientific Title
Validation of atrial fibrillation screening strategies in patients with ischemic heart disease using artificial intelligence electrocardiography (CVI ARO 21 Study)
Scientific Title:Acronym
Validation of atrial fibrillation screening strategies in patients with ischemic heart disease using artificial intelligence electrocardiography (CVI ARO 21 Study)
Region
| Japan |
Condition
Condition
Ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Evaluate the availability of seal-designed Holter ECG in patients with ischemic disease and high risk for atrial fibrillation by real-time risk alert derived from artificial intelligence enhanced sinus rhythm ECG.
Basic objectives2
Others
Basic objectives -Others
To Evaluate the availability of seal-designed Holter ECG in patients with ischemic disease and high risk for atrial fibrillation by real-time risk alert derived from artificial intelligence enhanced sinus rhythm ECG.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic rate of atrial fibrillation by long-term Holter ECG
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Hospitalized patients in order to perform CAG or PCI at our hospital and with AI-ECG enhanced AF risk score >= 0.8.
(2) Out-hospital patients with AI-ECG enhanced AF risk score >= 0.8 and Suita risk score >=12.
Key exclusion criteria
Patients who do not consent to research participation.
Target sample size
197
Research contact person
Name of lead principal investigator
| 1st name | Naomi |
| Middle name | |
| Last name | Hirota |
Organization
The Cardiovascular Institute
Division name
Department of Cardiovascular Medicine
Zip code
106-0031
Address
3-2-19 Nishi-Azabu, Minato-ku, Tokyo, Japan
TEL
03-3408-2151
n-hirota@cvi.or.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Hirota |
Organization
The Cardiovascular Institute
Division name
Department of Cardiovascular Medicine
Zip code
106-0031
Address
3-2-19 Nishi-Azabu, Minato-ku, Tokyo, Japan
TEL
03-3408-2151
Homepage URL
n-hirota@cvi.or.jp
Sponsor or person
Institute
The Cardiovascular Institute
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nihon Kohden Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Cardiovascular Institute
Address
3-2-19 Nishi-Azabu, Minato-ku, Tokyo, Japan
Tel
03-3408-2151
matsuda@cvi.or.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 | 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
| 2024 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, the diagnostic rate of atrial fibrillation using long-term Holter ECG in target patients are evaluated.
Management information
Registered date
| 2026 | Year | 03 | Month | 24 | Day |
Last modified on
| 2026 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069560
