Trial Outcomes & Findings for Validation of WatchBP Office Ankle-brachial Index (ABI) Function (NCT NCT01002989)
NCT ID: NCT01002989
Last Updated: 2012-01-23
Results Overview
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.
COMPLETED
98 participants
once (cross-sectional)
2012-01-23
Participant Flow
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
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
|
98
|
|
Overall Study
COMPLETED
|
93
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
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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|---|---|
|
Overall Study
exclusion criteria, no consent
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5
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Baseline Characteristics
Validation of WatchBP Office Ankle-brachial Index (ABI) Function
Baseline characteristics by cohort
| Measure |
Hypertensives
n=98 Participants
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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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=99 Participants
|
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Age, Categorical
>=65 years
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44 Participants
n=99 Participants
|
|
Age Continuous
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62.5 years
STANDARD_DEVIATION 11.1 • n=99 Participants
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Sex: Female, Male
Female
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37 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=99 Participants
|
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Region of Enrollment
Greece
|
98 participants
n=99 Participants
|
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Mean Doppler ABI
|
1.08 ratio
STANDARD_DEVIATION 0.17 • n=99 Participants
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|
Watch BP Office minus Doppler Ankle-Brachial Index (ABI) difference
|
0.03 ratio
STANDARD_DEVIATION 0.11 • n=99 Participants
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Mean Watch BP Office ABI
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1.11 ratio
STANDARD_DEVIATION 0.17 • n=99 Participants
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PRIMARY outcome
Timeframe: once (cross-sectional)Population: 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.
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.
Outcome measures
| Measure |
Hypertensives
n=93 Participants
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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|---|---|
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Watch BP Office Minus Doppler Ankle-Brachial Index Difference
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0.03 ratio
Standard Deviation 0.11
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PRIMARY outcome
Timeframe: once (cross-sectional)Outcome measures
| Measure |
Hypertensives
n=93 Participants
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).
|
|---|---|
|
Mean Doppler Ankle-Brachial Index
|
1.08 ratio
Standard Deviation 0.17
|
PRIMARY outcome
Timeframe: once (cross-sectional)Outcome measures
| Measure |
Hypertensives
n=93 Participants
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).
|
|---|---|
|
Mean Watch BP Office Ankle-Brachial Index
|
1.11 ratio
Standard Deviation 0.17
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SECONDARY outcome
Timeframe: Once (cross-sectional)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.
Outcome measures
| Measure |
Hypertensives
n=93 Participants
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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|---|---|
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Agreement Between the Two Methods in Peripheral Artery Disease (PAD) Diagnosis
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95 Percentage of participants
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Adverse Events
Hypertensives
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
George S. Stergiou, MD, FRCP, Associate Professor of Medicine
Hypertension Center, Third University Department of Medicine, Sotiria Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place