UMIN-CTR Clinical Trial

Basic information
Public title	Optimizing the detection methods for atrial fibrillation with irregular heartbeat detector during automated blood pressure measurement.
Acronym	Optimizing the detection methods for atrial fibrillation with irregular heartbeat detector during automated blood pressure measurement.
Scientific Title	Optimizing the detection methods for atrial fibrillation with irregular heartbeat detector during automated blood pressure measurement.
Scientific Title:Acronym	Optimizing the detection methods for atrial fibrillation with irregular heartbeat detector during automated blood pressure measurement.
Region	Japan

Condition
Condition	Atrial Fibrillation
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	A purpose of this study is to decide the most appropriate number of blood pressure measurements and irregular heartbeat occurrences for atrial fibrillation detection by using an automated blood pressure monitor with irregular heartbeat detector.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We use the Omron blood pressure monitor HME-907 and evaluate the performance (sensitivity, specificity, positive predictive value, negative predictive value, and accuracy) for detecting atrial fibrillation when irregular heartbeat is recorded at least once during three times of blood pressure measurements. We make the diagnosis of the atrial fibrillation based on the characteristic views (the uncertainty of the RR interval, disappearance of the P wave, appearance of the fibrillation wave) in the monitor electrocardiogram wave pattern.
Key secondary outcomes	We evaluate the performance for detecting atrial fibrillation by the following conditions. 1. Comparison by the number of measurement (once, twice, three times). 2. Comparison by the number of the irregular heart beat (once, twice, more than three times). 3. Comparison of the volume of the pulse pressure.

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
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who are hospitalized or visit outpatient clinic in Kagawa University Hospital. Patients who enter healthcare facilities for seniors in Kagawa.
Key exclusion criteria	Patients who cannot maintain rest in a sitting position. Patients who are inappropriate to measure blood pressure in an upper arm such as dialysis patients. Patients with pacemakers or defibrillators. Patients judged unsuitable as subjects.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tetsuo Minamino
Organization	School of Medicine, Kagawa University
Division name	Department of Cardiorenal and Cerebrovascular Medicine
Zip code
Address	1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL	+81-87-891-2150
Email	minamino@med.kagawa-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Makoto Ishizawa
Organization	School of Medicine, Kagawa University
Division name	Department of Cardiorenal and Cerebrovascular Medicine
Zip code
Address	1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL	+81-87-891-2150
Homepage URL
Email	ishizawa@med.kagawa-u.ac.jp

Sponsor
Institute	Kagawa University
Institute
Department

Funding Source
Organization	OMRON HEALTHCARE Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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IRB Contact (For public release)
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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	香川大学医学部附属病院（香川県）

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Results
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Baseline Characteristics
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Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date	2017 Year 04 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 06 Month 30 Day

Other

Other related information

Several blood pressure (BP) monitors include an irregular heartbeat detector, and Omron HME-907 is one of them. An irregular heartbeat is defined as a rhythm that varies more than 25% from the average rhythm detected while the monitor is measuring blood pressure. If atrial fibrillation can be appropriately detected by using the BP monitor with irregular heartbeat detector, it may lead to early diagnosis of atrial fibrillation. Some reports demonstrated the precision of atrial fibrillation detection in the past, but these reports showed different results. These differences may be caused by variation of patient profile or non-optimization of the measurement condition.

Management information
Registered date	2017 Year 07 Month 25 Day
Last modified on	2018 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032479

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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