UMIN-CTR Clinical Trial

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

Atrial Fibrillation

Classification by specialty

Medicine in general

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kagawa University

Institute

Department

Personal name

Organization

OMRON HEALTHCARE Co., Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

香川大学医学部附属病院（香川県）

Date of disclosure of the study information

2017

Year

07

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

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 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.

Registered date

2017

Year

07

Month

25

Day

Last modified on

2018

Year

08

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032479