UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062828 |
|---|---|
| Receipt number | R000071890 |
| Scientific Title | Association Between AI-Estimated Atrial Fibrillation Risk and Cardiac Functional and Structural Parameters: A Prospective Observational Study Using the FCP-9900Ai |
| Date of disclosure of the study information | 2026/09/10 |
| Last modified on | 2026/09/04 20:10:13 |
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Basic information
Public title
Association Between AI-Estimated Atrial Fibrillation Risk and Cardiac Functional and Structural Parameters: A Prospective Observational Study Using the FCP-9900Ai
Acronym
Association Between AI-Estimated Atrial Fibrillation Risk and Cardiac Functional and Structural Parameters: A Prospective Observational Study Using the FCP-9900Ai
Scientific Title
Association Between AI-Estimated Atrial Fibrillation Risk and Cardiac Functional and Structural Parameters: A Prospective Observational Study Using the FCP-9900Ai
Scientific Title:Acronym
Association Between AI-Estimated Atrial Fibrillation Risk and Cardiac Functional and Structural Parameters: A Prospective Observational Study Using the FCP-9900Ai
Region
| Japan |
Condition
Condition
Patients undergoing electrocardiography and echocardiography who are in sinus rhythm at the time of examination
Classification by specialty
| Cardiology | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the association between AI-detected latent atrial fibrillation risk and cardiac function and structure by stratifying patients according to the risk grade detected by the FCP-9900Ai and comparing echocardiographic parameters among the groups.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association Between AI-Derived Atrial Fibrillation Risk Scores and Echocardiographic Parameters
Left atrial diameter (LAD) and left atrial volume index (LAVI)
Left ventricular diastolic function parameters (E/A ratio, e', and E/e' ratio)
Left ventricular ejection fraction (LVEF)
Left atrial strain
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 undergoing electrocardiography and echocardiography who are in sinus rhythm at the time of examination
Key exclusion criteria
(1) Patients receiving antiarrhythmic drugs
(2) Patients who have undergone catheter ablation
(3) Patients with a history of open-heart surgery
(4) Patients with an implanted pacemaker
(5) Patients with a history of cardioembolic stroke
(6) Patients with mitral stenosis
(7) Patients who have undergone prosthetic valve replacement
(8) Patients in whom echocardiographic findings cannot be obtained due to poor image quality
(9) Patients with atrial fibrillation or atrial flutter at the time of examination
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Sendo |
| Middle name | |
| Last name | Syo |
Organization
Kobe University Hospital
Division name
Department of Clinical Laboratory
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-6314
sho1000d@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Sendo |
| Middle name | |
| Last name | Syo |
Organization
Kobe University Hospital
Division name
Department of Clinical Laboratory
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-6314
Homepage URL
sho1000d@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuda Denshi Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Hospital
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
Tel
078-382-6314
sho1000d@med.kobe-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
| 2026 | Year | 09 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will analyze patients who underwent clinically indicated electrocardiography and echocardiography at our institution, including patients with left ventricular hypertrophy, such as those with cardiac amyloidosis, Fabry disease, or hypertrophic cardiomyopathy, as well as patients in whom assessment of left ventricular diastolic function is difficult.
Management information
Registered date
| 2026 | Year | 09 | Month | 04 | Day |
Last modified on
| 2026 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071890
