UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058921 |
|---|---|
| Receipt number | R000067387 |
| Scientific Title | Development of an AI Model for Detecting Heart Failure from Fundus Images |
| Date of disclosure of the study information | 2025/12/31 |
| Last modified on | 2025/08/28 23:55:13 |
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Basic information
Public title
Development of an AI Model for Detecting Heart Failure from Fundus Images
Acronym
Development of an AI Model for Detecting Heart Failure from Fundus Images
Scientific Title
Development of an AI Model for Detecting Heart Failure from Fundus Images
Scientific Title:Acronym
Development of an AI Model for Detecting Heart Failure from Fundus Images
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Fundus findings, including retinal arteries, may contain information on the early stages of heart disease. This study aims to develop an artificial intelligence (AI) model that can automatically predict heart failure using fundus images obtained non-invasively with a non-mydriatic fundus camera.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Accuracy of an AI model for predicting lifestyle-related diseases and elevated NT-proBNP, and for estimating cardiovascular disease (sensitivity, specificity, positive predictive value, negative predictive value)
Key secondary outcomes
Correlation between AI-derived risk scores and outcomes (mortality and incidence of cardiovascular events)
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
(1) Adults aged 20 years or older
(2)Patients with cardiovascular disease who are outpatients or inpatients at the Department of Cardiovascular Medicine, The University of Tokyo Hospital, or Moriyama Memorial Hospital
(3)Employees of the Meiji Yasuda Health Insurance Association who undergo health checkups
Participants who meet criterion (1) and either (2) or (3), and who provide informed consent to participate in this study, will be included.
Key exclusion criteria
Patients who do not provide informed consent to participate in the study
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Eriko |
| Middle name | |
| Last name | Hasumi |
Organization
The University of Tokyo Hospital
Division name
Department of cardiology
Zip code
113-8655
Address
1-7-3 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
38155411
ehasumi@gmail.com
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Hasumi |
Organization
The University of Tokyo Hospital
Division name
Department of cardiology
Zip code
113-8655
Address
1-7-3 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
0338155411
Homepage URL
ehasumi@gmail.com
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Eriko Hasumi
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo Hospital
Address
1-7-3 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
0338155411
ehasumi@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
東京都
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruitment will be conducted among outpatients or inpatients at the Department of Cardiovascular Medicine, The University of Tokyo Hospital, and Moriyama Memorial Hospital, as well as among employees of the Meiji Yasuda Health Insurance Association undergoing health checkups. After obtaining informed consent, fundus images will be captured using a portable fundus camera, and blood sampling and clinical data collection will be performed. These data will then be analyzed to develop the AI model.
Management information
Registered date
| 2025 | Year | 08 | Month | 28 | Day |
Last modified on
| 2025 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067387
