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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Atrial Fibrillation | ||
Classification by specialty |
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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 | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 300 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
minamino@med.kagawa-u.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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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 | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032479 |
Research Plan | |
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Research case data specifications | |
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Research case data | |
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