UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000032458