UMIN-CTR Clinical Trial

Basic information
Public title	Development and performance evaluation of a new atrial fibrillation detection system using finger volume pulse wave
Acronym	Development and performance evaluation of a new atrial fibrillation detection system using finger volume pulse wave
Scientific Title	Development and performance evaluation of a new atrial fibrillation detection system using finger volume pulse wave
Scientific Title:Acronym	Development and performance evaluation of a new atrial fibrillation detection system using finger volume pulse wave
Region	Japan

Condition
Condition	atrial fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this project is to develop a new system for detecting atrial fibrillation using finger volume pulse wave data and to evaluate the performance of the system.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sensitivity and specificity of the Atrial Fibrillation Detection System in the diagnosis of atrial fibrillation.
Key secondary outcomes

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients who are attending or being admitted to the Department of Cardiology of this hospital 2) Men and women who are 20 years of age or older at the time consent is obtained. 3) Patients who have been fully informed about their participation in the study, and who have given written consent of their own free will based on sufficient understanding. 4) Patients with a confirmed diagnosis of sinus rhythm or atrial fibrillation based on electronic medical record information or electrocardiography performed within the scope of normal medical care.
Key exclusion criteria	1) Patients unable to maintain rest in a sitting position 2) Patients who have difficulty with fingertip volumetric pulse wave measurement (patients who have difficulty keeping their fingers still for reasons such as hand tremor) 3) Patients after pacemaker implantation or defibrillator implantation 4) Other patients deemed inappropriate as subjects by the principal investigator.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Tetsuo Middle name Last name Minamino
Organization	Kagawa University, School of medicine
Division name	Cardiorenal and Cerebrovascular Medicine
Zip code	761-0793
Address	1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL	087-891-2150
Email	minamino.tetsuo.gk@kagawa-u.ac.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Ishizawa
Organization	Kagawa University, School of medicine
Division name	Cardiorenal and Cerebrovascular Medicine
Zip code	761-0793
Address	1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL	087-891-2150
Homepage URL
Email	ishizawa.makoto@kagawa-u.ac.jp

Sponsor
Institute	Kagawa University
Institute
Department

Funding Source
Organization	Melody International Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	The National Institute of Advanced Industrial Science and Technology
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The ethics committee of Kagawa University Faculty of Medicine
Address	1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
Tel	087-898-5111
Email	kenkyushien@kagawa-u.ac.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	2022 Year 08 Month 03 Day

Related information
URL releasing protocol	https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f6.cgi
Publication of results	Unpublished

Result
URL related to results and publications	https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f6.cgi
Number of participants that the trial has enrolled	40
Results	Accurate evaluation was not possible due to noise during phalangeal volume pulse wave measurement, and the goal was not achieved.
Results date posted	2022 Year 08 Month 03 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Sinus rhythm (N=15), Atrial fibrillation (N=15) Mean age: 65.7, 70 Males (%): 46.7, 73.3 Combination of underlying disorders (%) Hypertension: 80, 53.3 Lipid disorders: 46.7, 13.3 Deficiency heart disease: 33.3, 26.7 Heart failure: 20, 53.3 Diabetes mellitus: 20, 20 Vascular disorders: 6.7, 6.7
Participant flow	Achieved target number of patients to be enrolled.
Adverse events	none
Outcome measures	unassessable
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 10 Month 20 Day
Date of IRB	2020 Year 10 Month 20 Day
Anticipated trial start date	2020 Year 12 Month 10 Day
Last follow-up date	2021 Year 01 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	One-minute finger volume pulse wave measurements and ECG monitor recordings were performed on 15 patients in sinus rhythm and 15 patients in atrial fibrillation. However, due to problems with the finger volume pulse wave measurement equipment, accurate data could not be obtained in 13 of the total 30 patients, making the targeted performance evaluation impossible.

Management information
Registered date	2022 Year 08 Month 03 Day
Last modified on	2022 Year 08 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055347