UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021321 |
|---|---|
| Receipt number | R000024003 |
| Scientific Title | Validation of Arrhythmia Diagnosis using Wrist Watch type Pulse wave machine. |
| Date of disclosure of the study information | 2016/03/30 |
| Last modified on | 2020/03/09 11:59:55 |
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Basic information
Public title
Validation of Arrhythmia Diagnosis using Wrist Watch type Pulse wave machine.
Acronym
Arrhythmia Diagnosis using Wrist Watch type Pulse wave machine.
Scientific Title
Validation of Arrhythmia Diagnosis using Wrist Watch type Pulse wave machine.
Scientific Title:Acronym
Arrhythmia Diagnosis using Wrist Watch type Pulse wave machine.
Region
| Japan |
Condition
Condition
Atrial Fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the validation of arrhythmic diagnosis using wrist watch type pulse wave monitoring
Basic objectives2
Others
Basic objectives -Others
Validation of arrhythmia diagnosis
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic rate
sensitivity, specificity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
arrhythmia diagnosis by pulse wave
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Atrial Fibrillation
Key exclusion criteria
none
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kengo |
| Middle name | |
| Last name | Kusano |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular Medicine
Zip code
564-8565
Address
6-1Kishibeshinmachi,Suita,Osaka
TEL
+81661701070
kusanokengo@hotmail.com
Public contact
Name of contact person
| 1st name | Kengo |
| Middle name | |
| Last name | Kusano |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular Medicine
Zip code
564-8565
Address
6-1Kishibeshinmachi,Suita,Osaka
TEL
+81661701070
Homepage URL
kusanokengo@hotmail.com
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee
Address
6-1Kishibeshinmachi,Suita,Osaka
Tel
+81661701070
rec-office-ac@ncvc.go.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
| 2016 | Year | 03 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
136
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
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 23 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 03 | Day |
Last modified on
| 2020 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024003
