UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057376 |
|---|---|
| Receipt number | R000065565 |
| Scientific Title | Kyoto AF Screening Study: Integrating Apple Watch with Expert Analysis |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/03/24 16:12:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Kyoto AF Screening Study: Integrating Apple Watch with Expert Analysis
Acronym
Kyoto AF Screening Study
Scientific Title
Kyoto AF Screening Study: Integrating Apple Watch with Expert Analysis
Scientific Title:Acronym
Kyoto AF Screening Study
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to improve the early detection of atrial fibrillation and the rate of therapeutic intervention using the Apple Watch and the newly developed NO MORE STROKE application.
Basic objectives2
Others
Basic objectives -Others
Observation of hospital visit rates and treatment intervention rates
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
At the end of the two-month follow-up
o Increased rate of hospital visit
Key secondary outcomes
At the end of the two-month follow-up
o Rate of therapeutic intervention by patients receiving feedback from partner cardiologists
o Continued app usage and satisfaction of users
o Comparison of hospital visit rates by region (Kyoto City vs. Ayabe City)
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
| 60 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
iPhone users aged 60 and older living in Kyoto Prefecture (Kyoto City or Ayabe City)
Key exclusion criteria
Under 60 years of age
Non-iPhone users
Already indicated as having atrial fibrillation
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Keitaro |
| Middle name | |
| Last name | Senoo |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Cardiac Arrhythmia Research and Innovation
Zip code
602-8566
Address
465 Kajiichou, Hirokouji, Kawaramachi, Kamigyo-ku, Kyoto
TEL
08031117168
k-senoo@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Keitaro |
| Middle name | |
| Last name | Senoo |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Cardiac Arrhythmia Research and Innovation
Zip code
602-8566
Address
465 Kajiichou, Hirokouji, Kawaramachi, Kamigyo-ku, Kyoto
TEL
+818031117168
Homepage URL
k-senoo@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
NA
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB center Kyoto Prefectural University of Medicine
Address
465 Kajiichou, Hirokouji, Kawaramachi, Kamigyo-ku, Kyoto
Tel
0752515337
rinri@koto.kpu-m.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
| 2025 | Year | 07 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participants will use Apple Watch to record ECG regularly for two months. Data will be transmitted through the "NO MORE STROKE app" and analyzed by partner cardiologists.
If possible atrial fibrillation is detected, a pop-up message will notify users through the app, promoting the detailed analysis of ECG by cardiologists. The cardiologists' detailed analysis will be returned to users via the app, and if the possibility of atrial fibrillation is high, they will be encouraged to visit a hospital.
This process uses the ECG function of Apple Watch as the main tool for atrial fibrillation detection, observing how much the nudge effect by cardiologists leads to early hospital visits and treatment intervention.
Management information
Registered date
| 2025 | Year | 03 | Month | 24 | Day |
Last modified on
| 2025 | 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=R000065565
