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| Name | Class |
|---|---|
| Microlife | INDUSTRY |
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Measurement of the ankle-brachial index (ABI) with the oscillometric device WatchBP Office will be assessed compared to the reference method (Doppler).
Ninety three adult subjects assessed for hypertension, treated or untreated, with complete study data were included. Data on the presence of cardiovascular (CV) disease and classical CV risk factors were recorded.
All the ABI measurements of each individual participant will be performed by the same observer in a randomized order (concerning Doppler and WatchBP)
All study measurements were performed under standardized conditions in a quiet examination room with 10 min rest in the supine position before measurements. Ankle-brachial index (ABI) was measured manually by Doppler and automatically by the oscillometric device in randomized order by a single investigator. Manual Doppler ABI was measured according to the American Heart Association guidelines using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe. Systolic blood pressure was defined with a standard mercury sphygmomanometer by the first Doppler flow signal while deflating the cuff from a suprasystolic level in brachial, dorsalis pedis and posterior tibial arteries. Systolic pressure was determined sequentially for brachial, dorsalis pedis and posterior tibial arteries for each side and ABI was calculated for each leg by dividing the highest ankle pressure to the highest arm pressure. Automated ABI measurement was performed using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland). This device allows automated simultaneous both arms or arm and leg blood pressure measurements and thereby the calculation of ABI. The ABI results are displayed on the device screen.
The study protocol included three steps: (i) an introductory familiarization automated ABI measurement, (ii) three simultaneous oscillometric both arms blood pressure measurements; in case of a consistent inter-arm difference ≥12 mmHg, the arm with the higher blood pressure was selected for the subsequent oscillometric ABI measurements (otherwise the right arm was used) and (iii) Doppler and automated ABI measurement in randomized order; Doppler ABI was measured once, whereas automated ABI calculation included triplicate simultaneous arm-leg measurements performed for each side. The occurrence of five sequential oscillometric errors was defined as a failure of the oscillometric device to measure ABI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All eligible patients | Subjects assessed for hypertension, were subjected to the measurement of ankle brachial index (ABI) by two methods:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doppler Ankle-Brachial Index measurement | Device | Measurement of the Ankle-Brachial Index by Doppler. |
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| Measure | Description | Time Frame |
|---|---|---|
| Watch BP Office Minus Doppler Ankle-Brachial Index Difference | The validation process consisted of two parts: (i) measurement validation, which compared Doppler and Watch BP Office ABI values and assessed their association, and (ii) clinical validation, which compared the diagnosis of peripheral artery disease (PAD) by the two methods and assessed the association of Watch BP Office and Doppler ABI values with cardiovascular risk factors. | once (cross-sectional) |
| Mean Doppler Ankle-Brachial Index | once (cross-sectional) | |
| Mean Watch BP Office Ankle-Brachial Index | once (cross-sectional) |
| Measure | Description | Time Frame |
|---|---|---|
| Agreement Between the Two Methods in Peripheral Artery Disease (PAD) Diagnosis | This outcome measure represents what percentage of the patients diagnosed with PAD using Doppler ABI method (reference method) were diagnosed with PAD using WatchBP Office ABI method. It also represents in what percentage of the patients in whom PAD was excluded with Doppler ABI method (reference method), PAD was excluded using WatchBP Office ABI method as well. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects assessed for hypertension including those with other cardiovascular risk factors
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| Name | Affiliation | Role |
|---|---|---|
| George S Stergiou, Assoc. Prof. | Hypertension Center, University of Athens, Greece | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hypertension Center, Sotiria Hospital | Athens | 11527 | Greece |
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Patients with various cardiovascular risk factors attending a hypertension or a diabetes outpatient clinic during the period 10/2009-06/2010 were invited to participate in the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypertensives | Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Hypertensives | Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Watch BP Office Minus Doppler Ankle-Brachial Index Difference | The validation process consisted of two parts: (i) measurement validation, which compared Doppler and Watch BP Office ABI values and assessed their association, and (ii) clinical validation, which compared the diagnosis of peripheral artery disease (PAD) by the two methods and assessed the association of Watch BP Office and Doppler ABI values with cardiovascular risk factors. | Patients with various cardiovascular risk factors attending a hypertension or a diabetes outpatient clinic were invited to participate in the study. Subjects with atrial fibrillation or incompressible ankle arteries (ABI ≥1.4) were excluded. | Posted | Mean | Standard Deviation | ratio | once (cross-sectional) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hypertensives | Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George S. Stergiou, MD, FRCP, Associate Professor of Medicine | Hypertension Center, Third University Department of Medicine, Sotiria Hospital | +30 2107763117 | gstergi@med.uoa.gr |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| WatchBP Office Ankle-Brachial Index measurement. | Device | Measurement of Ankle-Brachial Index by WatchBP Office device. |
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| Once (cross-sectional) |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Mean Doppler ABI | Mean | Standard Deviation | ratio |
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| Watch BP Office minus Doppler Ankle-Brachial Index (ABI) difference | Mean | Standard Deviation | ratio |
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| Mean Watch BP Office ABI | Mean | Standard Deviation | ratio |
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| Secondary | Agreement Between the Two Methods in Peripheral Artery Disease (PAD) Diagnosis | This outcome measure represents what percentage of the patients diagnosed with PAD using Doppler ABI method (reference method) were diagnosed with PAD using WatchBP Office ABI method. It also represents in what percentage of the patients in whom PAD was excluded with Doppler ABI method (reference method), PAD was excluded using WatchBP Office ABI method as well. | Posted | Number | Percentage of participants | Once (cross-sectional) |
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| Primary | Mean Doppler Ankle-Brachial Index | Posted | Mean | Standard Deviation | ratio | once (cross-sectional) |
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| Primary | Mean Watch BP Office Ankle-Brachial Index | Posted | Mean | Standard Deviation | ratio | once (cross-sectional) |
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| 0 |
| 93 |
| 0 |
| 93 |
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