UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048571
Receipt number R000055347
Scientific Title Development and performance evaluation of a new atrial fibrillation detection system using finger volume pulse wave
Date of disclosure of the study information 2022/08/03
Last modified on 2022/08/03 17:56:16

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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 or person

Institute

Kagawa University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055347


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name