UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042073 |
|---|---|
| Receipt number | R000048014 |
| Scientific Title | Machine learning prediction of Heart failure and Arrythmia using the mobile self-monitoring ECG devices |
| Date of disclosure of the study information | 2020/10/11 |
| Last modified on | 2023/04/14 15:02:06 |
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Basic information
Public title
Machine learning prediction of Heart failure and Arrythmia using the mobile self-monitoring ECG devices
Acronym
Machine learning prediction of Heart failure and Arrythmia using the mobile self-monitoring ECG devices
Scientific Title
Machine learning prediction of Heart failure and Arrythmia using the mobile self-monitoring ECG devices
Scientific Title:Acronym
Machine learning prediction of Heart failure and Arrythmia using the mobile self-monitoring ECG devices
Region
| Japan |
Condition
Condition
Heart failure, Arrhythmia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
prediction of heart failure and arrhythmia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Onset of heart failure
Onset of arrhythmia (atrial fibrillation)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients with heart failure and healthy individuals,20 years old or older
Key exclusion criteria
Individual under 20 years
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Katsuhito |
| Middle name | |
| Last name | Fujiu |
Organization
University of Tokyo
Division name
Department of Cardiovascular Medicine
Zip code
113-8655
Address
7-3-1 Hongo Bunkyo-Ku
TEL
0338155411
fujiu-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Hasumi |
Organization
University of Tokyo
Division name
Department of Cardiovascular Medicine
Zip code
113-8655
Address
7-3-1 Hongo Bunkyo-Ku
TEL
0338155411
Homepage URL
ehasumi-circ@umin.ac.jp
Sponsor or person
Institute
University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
University of Tokyo
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
SIMPLEX QUANTUM
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo Hospital
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
0338155411
ethics@m.u-tokyo.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
| 2020 | Year | 10 | Month | 11 | 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
| 2020 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
ECG data obtained from adults participants using the single-lead ECG devices, and other clinical information are analyzed and evaluated.
Management information
Registered date
| 2020 | Year | 10 | Month | 11 | Day |
Last modified on
| 2023 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048014
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/04/13 | 資料１研究計画書_20200307.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
