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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028371
Receipt No. R000032479
Scientific Title Optimizing the detection methods for atrial fibrillation with irregular heartbeat detector during automated blood pressure measurement.
Date of disclosure of the study information 2017/07/28
Last modified on 2018/08/22

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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
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 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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
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

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
Registered date File name

Research case data
Registered date File name


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