UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028403 |
|---|---|
| Receipt number | R000032458 |
| Scientific Title | The use of a wristband type continuous pulse measurement device for early detection of paroxysmal atrial fibrillation: A pilot study. |
| Date of disclosure of the study information | 2017/07/27 |
| Last modified on | 2019/07/30 10:50:14 |
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Basic information
Public title
The use of a wristband type continuous pulse measurement device for early detection of paroxysmal atrial fibrillation: A pilot study.
Acronym
Wristband type pulse measurement for detecting paroxysmal atrial fibrillation.
Scientific Title
The use of a wristband type continuous pulse measurement device for early detection of paroxysmal atrial fibrillation: A pilot study.
Scientific Title:Acronym
Wristband type pulse measurement for detecting paroxysmal atrial fibrillation.
Region
| Japan |
Condition
Condition
paroxysmal atrial fibrillation
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By simultaneously recording and comparing changes in pulse rate at the onset of paroxysmal atrial fibrillation with central telemetric monitoring and wristband type continuous pulsation measurement, we sought to determine whether it is possible to detect unrecognized paroxysmal atrial fibrillation with the use of the wristband device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
The percentage at which the diagnostic result of the conventional monitoring method (central telemetric monitoring) of detecting paroxysmal atrial fibrillation matched the data obtained from the wristband device.
Key secondary outcomes
Incidence of paroxysmal atrial fibrillation.
Sensitivity and specificity of detecting paroxysmal atrial fibrillation using the wristband device.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient who underwent cardiac surgery.
Patients of age 20 to under 90 and who consented to the trial.
Key exclusion criteria
Patients on pacemaker.
Patients who are hypersensitive to rubber product.
Patients with skin disease or disorder at the site of the wristband
Patients who are considered unsuitable for the trial, as judged by the doctor(s) or those responsible for the safety of this trial.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Kohno |
Organization
Chiba University Hospital
Division name
Cardiovascular surgery
Zip code
2608677
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
043-222-7171
hkcw@mac.com
Public contact
Name of contact person
| 1st name | Tomohiko |
| Middle name | |
| Last name | Inui |
Organization
Chiba University Hospital
Division name
Cardiovascular surgery
Zip code
2608677
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
09080785544
Homepage URL
nuinui5762@yahoo.co.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Medcare 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
Chiba University Hospital Clinical Research Ethics Committee
Address
1-8-1, Inohana, Chuo-ku, Chiba-sity, Chiba-Prefecture
Tel
043-222-7171
nuinui5762@yahoo.co.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
千葉大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 27 | 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
40
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Because the research paper has not yet been approved by the submitted journal
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
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participants are required to wear a wristband type continuous pulse measurement device and be under surveillance with a central telemetric electrocardiography system during hospital stay. If atrial fibrillation is detected or suspected on the central system, a 12-lead electrocardiogram is performed. Concurrently, all pulse changes recorded on the wristband device is analyzed and verified for consistency with the records of the telemetry system and the results of the 12 lead electrocardiogram.
Management information
Registered date
| 2017 | Year | 07 | Month | 27 | Day |
Last modified on
| 2019 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032458
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