Unique ID issued by UMIN | UMIN000048571 |
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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 |
Development and performance evaluation of a new atrial fibrillation detection system using finger volume pulse wave
Development and performance evaluation of a new atrial fibrillation detection system using finger volume pulse wave
Development and performance evaluation of a new atrial fibrillation detection system using finger volume pulse wave
Development and performance evaluation of a new atrial fibrillation detection system using finger volume pulse wave
Japan |
atrial fibrillation
Cardiology |
Others
NO
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.
Efficacy
Exploratory
Sensitivity and specificity of the Atrial Fibrillation Detection System in the diagnosis of atrial fibrillation.
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
30
1st name | Tetsuo |
Middle name | |
Last name | Minamino |
Kagawa University, School of medicine
Cardiorenal and Cerebrovascular Medicine
761-0793
1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
087-891-2150
minamino.tetsuo.gk@kagawa-u.ac.jp
1st name | Makoto |
Middle name | |
Last name | Ishizawa |
Kagawa University, School of medicine
Cardiorenal and Cerebrovascular Medicine
761-0793
1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
087-891-2150
ishizawa.makoto@kagawa-u.ac.jp
Kagawa University
Melody International Ltd.
Profit organization
The National Institute of Advanced Industrial Science and Technology
The ethics committee of Kagawa University Faculty of Medicine
1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
087-898-5111
kenkyushien@kagawa-u.ac.jp
NO
2022 | Year | 08 | Month | 03 | Day |
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f6.cgi
Unpublished
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f6.cgi
40
Accurate evaluation was not possible due to noise during phalangeal volume pulse wave measurement, and the goal was not achieved.
2022 | Year | 08 | Month | 03 | Day |
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
Achieved target number of patients to be enrolled.
none
unassessable
Completed
2020 | Year | 10 | Month | 20 | Day |
2020 | Year | 10 | Month | 20 | Day |
2020 | Year | 12 | Month | 10 | Day |
2021 | Year | 01 | Month | 26 | Day |
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.
2022 | Year | 08 | Month | 03 | Day |
2022 | Year | 08 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055347
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