UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055416 |
|---|---|
| Receipt number | R000056273 |
| Scientific Title | Comparison of heart rate monitoring with a telemetric single-lead electrocardiograph and an Apple Watch |
| Date of disclosure of the study information | 2024/09/04 |
| Last modified on | 2024/09/04 13:45:54 |
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Basic information
Public title
Comparison of heart rate monitoring with a telemetric single-lead electrocardiograph and an Apple Watch
Acronym
Comparison of heart rate monitoring with a telemetric single-lead electrocardiograph and an Apple Watch
Scientific Title
Comparison of heart rate monitoring with a telemetric single-lead electrocardiograph and an Apple Watch
Scientific Title:Acronym
Comparison of heart rate monitoring with a telemetric single-lead electrocardiograph and an Apple Watch
Region
| Japan |
Condition
Condition
not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of heart rate monitoring with a telemetric single-lead electrocardiograph and an Apple Watch
Basic objectives2
Others
Basic objectives -Others
NO
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Agreement between ECG and Apple Watch heart rate readings
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Free will consent to participate in research can be obtained in writing from the individual.
(2) Adult male who is at least 20 years old and less than 40 years old at the time of obtaining consent
Key exclusion criteria
(1) History of cardiac disease
(2) Taking sleeping pills or anti-anxiety medication
(3) Smoking
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hideto |
| Middle name | |
| Last name | Imai |
Organization
Kyoto Prefectural University of Medicine
Division name
Graduate School of Health Nursing
Zip code
602-8566
Address
465 Kaji-cho, Kawaramachi-Dori Hirokoji-Agaru, Kamigyo-ku, Kyoto
TEL
09097069289
km224201@stu.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Hideto |
| Middle name | |
| Last name | Imai |
Organization
Kyoto Prefectural University of Medicine
Division name
Graduate School of Health Nursing
Zip code
602-8566
Address
465 Kaji-cho, Kawaramachi-Dori Hirokoji-Agaru, Kamigyo-ku, Kyoto
TEL
09097069289
Homepage URL
km224201@stu.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine Medical Ethics Review Committee
Address
465 Kaji-cho, Kawaramachi-Dori Hirokoji-Agaru, Kamigyo-ku, Kyoto
Tel
075-251-5111
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
| 2024 | Year | 09 | Month | 04 | 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
Main results already published
Date of protocol fixation
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 09 | Month | 04 | Day |
Last modified on
| 2024 | 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=R000056273
