UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000048571
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.