UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048959 |
|---|---|
| Receipt number | R000055783 |
| Scientific Title | Investigation of the actual condition of patients with cardiac disease at home and in the outpatient setting using pulse oximeters. |
| Date of disclosure of the study information | 2022/09/18 |
| Last modified on | 2022/09/18 13:30:19 |
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Basic information
Public title
Investigation of the actual condition of patients with cardiac disease at home and in the outpatient setting using pulse oximeters.
Acronym
Fact-finding Survey of Cardiac Patients
Scientific Title
Investigation of the actual condition of patients with cardiac disease at home and in the outpatient setting using pulse oximeters.
Scientific Title:Acronym
Fact-finding survey using pulse oximeter
Region
| Japan |
Condition
Condition
heart disease
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Arrhythmia detection
Basic objectives2
Others
Basic objectives -Others
Exercise function evaluation, ECG
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Arrhythmia detection
Key secondary outcomes
Exercise instruction and its relationship to exercise
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Wearing continuous monitoring equipment during exercise and daily activities
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
heart disease
Key exclusion criteria
Dementia
Difficulty using equipment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshitatsu |
| Middle name | |
| Last name | Fukuta |
Organization
Asahi University Hospital
Division name
Cardiology, Rehabilitation
Zip code
500-8523
Address
3-23 Hashimoto-cho, Gifu City, Gifu
TEL
058-253-8001
yoshitatsu.f@gmail.com
Public contact
Name of contact person
| 1st name | Yoshitatsu |
| Middle name | |
| Last name | Fukuta |
Organization
Asahi University Hospital
Division name
Cardiology, Rehabilitation
Zip code
500-8523
Address
3-23 Hashimoto-cho, Gifu City, Gifu
TEL
058-253-8001
Homepage URL
yoshitatsu.f@gmail.com
Sponsor or person
Institute
Asahi University Hospital
Institute
Department
Personal name
Funding Source
Organization
Sanei Medicis Corporation
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
Asahi University Hospital
Address
3-23 Hashimoto-cho, Gifu City, Gifu
Tel
058-253-8001
yoshitatsu.f@gmail.com
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
| 2022 | Year | 09 | Month | 18 | 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
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 18 | Day |
Last modified on
| 2022 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055783
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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