UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057225 |
|---|---|
| Receipt number | R000065413 |
| Scientific Title | Clinical trial on the diagnostic sensitivity of atrial fibrillation using a portable electrocardiograph for home use |
| Date of disclosure of the study information | 2025/03/06 |
| Last modified on | 2026/04/28 16:52:08 |
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Basic information
Public title
Clinical trial on the diagnostic sensitivity of atrial fibrillation using a portable electrocardiograph for home use
Acronym
Clinical trial on the diagnostic sensitivity of atrial fibrillation using a portable electrocardiograph for home use
Scientific Title
Clinical trial on the diagnostic sensitivity of atrial fibrillation using a portable electrocardiograph for home use
Scientific Title:Acronym
Clinical trial on the diagnostic sensitivity of atrial fibrillation using a portable electrocardiograph for home use
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study will provide telemonitoring of electrocardiograms and communication of the possible presence of arrhythmias, including suspected atrial fibrillation, through telemedicine without the need for a hospital visit.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total diagnosis rate per month of paroxysmal atrial fibrillation diagnosed when a portable electrocardiograph is used in persons whose atrial fibrillation was not detected by 24-hour Holter ECG
Key secondary outcomes
(1) Usage of portable electrocardiographs (by day, by time of day, etc.)
(2) Total number of paroxysmal atrial fibrillation detected (individual and population)
(3) Detection rate by measurement compliance (adjusted by measurement frequency)
(4) Rate of visits to secondary medical institutions (research institutions) by persons suspected of having paroxysmal atrial fibrillation based on the measurement results of portable electrocardiographs
(5) Reasons why persons suspected of having paroxysmal atrial fibrillation based on the measurement results of the portable electrocardiograph did not visit a secondary medical institution.
(6) Correlation between diagnosis status of paroxysmal atrial fibrillation and various survey items
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients with a suspected arrhythmia who have undergone a 24-hour ECG test with no abnormalities will be monitored remotely for six months using the HCG-8060T home-use portable electrocardiograph (Omron Healthcare), and if an arrhythmia is detected, a remote health care consultation will be provided.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Those who have undergone 24-hour ECG test
(2) Those who are 45 years of age or older at the time of obtaining consent, or individuals aged 18 or older with underlying cardiovascular conditions
(3) Those who have a smartphone running the Omron Connect app
(4) Those who have requested home electrocardiogram measurement using a portable electrocardiograph
(5) Those who wish to have a telehealth medical consultation to communicate suspected findings
(6) Those who agree to participate in this study.
Key exclusion criteria
(1) Patients diagnosed with persistent atrial fibrillation
(2) Patients receiving anti-arrhythmic drugs
(3) Pregnant or possibly pregnant
(4) Patients with drug dependence or psychiatric disorders
(5) Patients participating in other clinical trials
(6) Patients with other serious diseases
(7) Patients who are deemed inappropriate by the physician
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Yatabe |
Organization
Fukushima Medical University, School of Medicine
Division name
Department of Digital Health Services Research
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima city, Fukushima, Japan
TEL
024-547-1206
jyatabe@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Yatabe |
Organization
Fukushima Medical University, School of Medicine
Division name
Department of Digital Health Services Research
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima city, Fukushima, Japan
TEL
024-547-1206
Homepage URL
jyatabe@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
OMRON HEALTHCARE 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
Institutional Review Board, Fukushima Medical University
Address
1 Hikarigaoka, Fukushima city, Fukushima, Japan
Tel
024-547-1825
rs@fmu.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 | 03 | Month | 06 | 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
| 2024 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 06 | Day |
Last modified on
| 2026 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065413
