UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043390 |
|---|---|
| Receipt number | R000049540 |
| Scientific Title | Development of a flail evaluation application based on deep learning |
| Date of disclosure of the study information | 2021/02/19 |
| Last modified on | 2024/02/22 09:21:39 |
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Basic information
Public title
Development of a flail evaluation application based on deep learning
Acronym
Development of a flail evaluation application based on deep learning
Scientific Title
Development of a flail evaluation application based on deep learning
Scientific Title:Acronym
Development of a flail evaluation application based on deep learning
Region
| Japan |
Condition
Condition
Chronic Heart Failure
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop an application for evaluating frailty based on objective evidence that can be used on smartphones and tablet devices.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of flail estimated by deep learning with existing indicators.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Flail group
Patients who have given written consent for the recording of walking videos at Hokkaido University Hospital and other collaborating facilities in the previously approved clinical research project "Epidemiological Multicenter Study for Tailored Treatment in Heart Failure".
2)Healthy group
Patients must have no history of heart failure, be 18 years of age or older at the time of consent, and have a score of 1 or 2 on the Clinical Frailty Scale. The recruitment of the healthy group will be done by posting posters in the hospital.
3) Heart failure group
1. Patients 18 years of age or older
2. Those diagnosed with symptomatic heart failure
3. Those who have given consent for the prognostic survey*1
4. Subjects who have received a thorough explanation of their participation in this study, and who have given their consent in writing of their own free will based on a thorough understanding of the subject.
Key exclusion criteria
(1) Frail group
1) Those who are judged by the principal investigator to be inappropriate as research subjects
(2) Healthy group
1) Those who are under 20 years of age at the time of obtaining consent
2) Those who are judged by the principal investigator to be inappropriate as research subjects.
3) Those with a score of 3 or more on the Clinical Frailty Scale
3) Heart failure group
1 Persons under 18 years old at the time of obtaining consent
2 Those who refuse to participate in the prognostic survey
3 Those deemed inappropriate as research subjects by the principal investigator
Target sample size
1400
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Nagai |
Organization
Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name
Department of Cardiovascular Medicine
Zip code
060-8638
Address
Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan
TEL
011-706-6973
nagai@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Mizuguchi |
Organization
Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name
Department of Cardiovascular Medicine
Zip code
060-8638
Address
Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan
TEL
011-706-6973
Homepage URL
mizu-tay@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Non profit foundation
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
Hokkaido University Faculty of Medicine and Graduate School of Medicine Independent Clinical Research Review Committee
Address
Kita 15 Nishi 7, Kita-ku, Sapporo, Hokkaido
Tel
011-706-5003
shomu@med.hokudai.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
| 2021 | Year | 02 | 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
| 2020 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2035 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2035 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2035 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 02 | Month | 19 | Day |
Last modified on
| 2024 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049540
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
