Validation of WatchBP Office Ankle-brachial Index (ABI) Function (ABI)
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)
Device: Doppler Ankle-Brachial Index measurement
Device: WatchBP Office Ankle-Brachial Index measurement.
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Assessment of the Oscillometric Measurement of the Ankle-brachial Index (ABI) With WatchBP Office ABI Device.|
- Watch BP Office Minus Doppler Ankle-Brachial Index Difference [ Time Frame: once (cross-sectional) ] [ Designated as safety issue: No ]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.
- Mean Doppler Ankle-Brachial Index [ Time Frame: once (cross-sectional) ] [ Designated as safety issue: No ]
- Mean Watch BP Office Ankle-Brachial Index [ Time Frame: once (cross-sectional) ] [ Designated as safety issue: No ]
- Agreement Between the Two Methods in Peripheral Artery Disease (PAD) Diagnosis [ Time Frame: Once (cross-sectional) ] [ Designated as safety issue: No ]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.
|Study Start Date:||June 2009|
|Study Completion Date:||June 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
All eligible patients
Subjects assessed for hypertension, were subjected to the measurement of ankle brachial index (ABI) by two methods:
Device: Doppler Ankle-Brachial Index measurement
Measurement of the Ankle-Brachial Index by Doppler.Device: WatchBP Office Ankle-Brachial Index measurement.
Measurement of Ankle-Brachial Index by WatchBP Office device.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01002989
|Hypertension Center, Sotiria Hospital|
|Athens, Greece, 11527|
|Principal Investigator:||George S Stergiou, Assoc. Prof.||Hypertension Center, University of Athens, Greece|