Validation of WatchBP Office Ankle-brachial Index (ABI) Function

NCT01002989 | Completed Results

• 1 other identifier: Microlife ABI
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Conditions

Hypertension

Keywords

ankle brachial index; WatchBP Office; oscillometric measurement

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (1)

• Agreement Between the Two Methods in Peripheral Artery Disease (PAD) Diagnosis

  Once (cross-sectional)

Study Arms (1)

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.

Device: Doppler Ankle-Brachial Index measurement; Device: WatchBP Office Ankle-Brachial Index measurement.

Interventions

Doppler Ankle-Brachial Index measurement DEVICE

Measurement of the Ankle-Brachial Index by Doppler.

All eligible patients

WatchBP Office Ankle-Brachial Index measurement. DEVICE

Measurement of Ankle-Brachial Index by WatchBP Office device.

All eligible patients

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects assessed for hypertension including those with other cardiovascular risk factors

You may qualify if:

• Treated or untreated subjects assessed for hypertension

You may not qualify if:

• Atrial fibrillation
• Incompressible ankle arteries

Sponsors & Collaborators

• University of Athens: lead
• Microlife: collaborator

Study Sites (1)

Hypertension Center, Sotiria Hospital

Athens, 11527, Greece

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: George S. Stergiou, MD, FRCP, Associate Professor of Medicine
• Organization: Hypertension Center, Third University Department of Medicine, Sotiria Hospital

gstergi@med.uoa.gr

+30 2107763117

Study Officials

• George S Stergiou, Assoc. Prof.

  Hypertension Center, University of Athens, Greece

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and Hypertension

Study Record Dates

• First Submitted: October 27, 2009
• First Posted: October 28, 2009
• Study Start: June 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: June 1, 2010
• Last Updated: January 23, 2012
• Results First Posted: January 13, 2012

Record last verified: 2012-01

Locations

GR (1)