UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052525 |
|---|---|
| Receipt number | R000059936 |
| Scientific Title | Large-Scale Clinical Study Investigating the Relationship between Physical Activity with Smartwatch and AI Output |
| Date of disclosure of the study information | 2023/10/19 |
| Last modified on | 2023/10/21 13:35:00 |
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Basic information
Public title
Large-Scale Clinical Study Investigating the Relationship between Physical Activity with Smartwatch and AI Output
Acronym
Large-Scale Clinical Study Investigating the Relationship between Physical Activity with Smartwatch and AI Output
Scientific Title
Large-Scale Clinical Study Investigating the Relationship between Physical Activity with Smartwatch and AI Output
Scientific Title:Acronym
Large-Scale Clinical Study Investigating the Relationship between Physical Activity with Smartwatch and AI Output
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analyzing the Relationship between Data Sent by Participants and Heart Failure:
1)Development of AI for Early Detection (Primary Prevention) of Heart Failure
2)Development of an AI Algorithm to Assess the Severity of Heart Failure"
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The diagnostic accuracy of the AI model in detecting heart failure
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
| 22 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 ged 22 years or older (including those with pacemakers).
2 Residing in Japan.
3 Possessing an Apple Watch.
Key exclusion criteria
1 Under the age of 22.
2 Residing overseas.
3 Do not own an Apple Watch.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Katsuhito |
| Middle name | |
| Last name | Fujiu |
Organization
The university of Tokyo hospital
Division name
The Department of Cardiovascular Medicine
Zip code
1138655
Address
7-3-1 Hongo Nunkyo-ku, Tokyo
TEL
+81-03-3815-5411
fujiu-tky@g.ecc.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Hasumi |
Organization
The university of Tokyo hospital
Division name
The Department of Cardiovascular Medicine
Zip code
113-8655
Address
7-3-1 Hongo Nunkyo-ku, Tokyo
TEL
0338155411
Homepage URL
ehasumi-circ@umin.ac.jp
Sponsor or person
Institute
The university of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The university of Tokyo hospital
Address
7-3-1 Hongo Nunkyo-ku, Tokyo
Tel
0338155411
ehasumi-circ@umin.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 | 10 | Month | 19 | 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
| 2023 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study collected information from recruited participants via open recruitment, including personal information, medical history, lifestyle, and physical activity data through iPhone, along with electrocardiogram measurements obtained using an Apple Watch. The observation aims to evaluate whether an algorithm for heart failure detection AI can automatically assist in diagnosing heart failure based on the transmitted electrocardiogram data.
Management information
Registered date
| 2023 | Year | 10 | Month | 17 | Day |
Last modified on
| 2023 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059936
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
