HypertensionABINCT01002989
Validation of WatchBP Office Ankle-brachial Index (ABI) Function
An observational study of Hypertension, run by University of Athens at 1 site in Greece.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Doppler Ankle-Brachial Index measurement and WatchBP Office Ankle-Brachial Index measurement.
- Type of treatment
- Medical device
- How many people
- 98 participants
- Where
- 1 siteGreece
- Study dates
- Jun 2009to Jun 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects assessed for hypertension including those with other cardiovascular risk factors
Who may be able to join
- Treated or untreated subjects assessed for hypertension
Who cannot join
- Atrial fibrillation
- Incompressible ankle arteries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Oscillometric Measurement of the Ankle-brachial Index (ABI) With WatchBP Office ABI Device.
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)
Read the detailed description
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.
- Conditions
- Hypertension
- Being tested
- Doppler Ankle-Brachial Index measurement, WatchBP Office Ankle-Brachial Index measurement.
- Keywords
- ankle brachial index, WatchBP Office, oscillometric measurement
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler Ankle-Brachial Index measurementDevice
Measurement of the Ankle-Brachial Index by Doppler.
WatchBP Office Ankle-Brachial Index measurement.Device
Measurement of Ankle-Brachial Index by WatchBP Office device.
| Study group | Role | What they receive |
|---|---|---|
| All eligible patients | Subjects assessed for hypertension, were subjected to the measurement of ankle brachial index (ABI) by two methods:
1. Doppler
2. WatchBP Office oscillometric The order for performing the two methods was randomized. Receives: Device: Doppler Ankle-Brachial Index measurement; Device: WatchBP Office Ankle-Brachial Index measurement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: once (cross-sectional)
Mean Doppler Ankle-Brachial Index
Measured: once (cross-sectional)
Mean Watch BP Office Ankle-Brachial Index
Measured: once (cross-sectional)
Secondary outcomes (1)
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.
Measured: Once (cross-sectional)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Microlife
- Responsible party
- Principal investigator, George S. Stergiou, University of Athens
- Investigators
- George S Stergiou, Assoc. Prof., Principal investigator, Hypertension Center, University of Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002989
- Sponsor's protocol ID
- Microlife ABI
- Acronym
- ABI
- Status last verified
- Jan 2012
- First submitted
- 27 Oct 2009
- Last updated
- 23 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Oscillometric Measurement of the Ankle-brachial Index (ABI) With WatchBP Office ABI Device.
- ClinicalTrials.gov ID
- NCT01002989
- Acronym / sponsor ID
- ABI / Microlife ABI
- Conditions
- Hypertension
- Keywords
- ankle brachial index, WatchBP Office, oscillometric measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Collaborators
- Microlife
- Study start
- Jun 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 28 Oct 2009 (estimated)
- Results
- Posted 13 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All eligible patients | – | Device: Doppler Ankle-Brachial Index measurement, Device: WatchBP Office Ankle-Brachial Index measurement.Subjects assessed for hypertension, were subjected to the measurement of ankle brachial index (ABI) by two methods: 1. Doppler 2. WatchBP Office oscillometric The order for performing the two methods was randomized. |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects assessed for hypertension including those with other cardiovascular risk factors
Key inclusion criteria (1 listed)
- Treated or untreated subjects assessed for hypertension
Key exclusion criteria (2 listed)
- Atrial fibrillation
- Incompressible ankle arteries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doppler Ankle-Brachial Index measurementMeasurement of the Ankle-Brachial Index by Doppler. | Device | All eligible patients |
| WatchBP Office Ankle-Brachial Index measurement.Measurement of Ankle-Brachial Index by WatchBP Office device. | Device | All eligible patients |
Primary outcome
Watch BP Office Minus Doppler Ankle-Brachial Index Difference
Time frame: once (cross-sectional)
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)
Mean Watch BP Office Ankle-Brachial Index
Time frame: once (cross-sectional)
1 secondary outcome
Agreement Between the Two Methods in Peripheral Artery Disease (PAD) Diagnosis
Time frame: Once (cross-sectional)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George S Stergiou, Assoc. Prof. principal investigator
Hypertension Center, University of Athens, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Watch BP Office Minus Doppler Ankle-Brachial Index Difference (time frame: once (cross-sectional)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2012.