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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028403
Receipt No. 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

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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
Email 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
Email nuinui5762@yahoo.co.jp

Sponsor
Institute Chiba University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032458

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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