Peripheral Arterial Disease Clinical Trial
Official title:
Validation of a Novel Oscillometric-Based Algorithm for Determination of the Ankle-Brachial Index
Verified date | February 2011 |
Source | Summit Doppler Systems, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
Peripheral arterial disease (PAD) is a highly prevalent medical condition. Patients with PAD
are usually diagnosed on the basis of the ankle-brachial index. The ankle-brachial index is
the ratio of ankle pressure to arm pressure after measurement of blood pressures in the arms
and legs using a Doppler device. The need for dedicated equipment and trained personnel,
along with the time required to perform the test, have been identified as barriers to
widespread implementation of ankle-brachial index screening. The use of automated
oscillometric devices for blood pressure measurement has been applied to leg pressure
measurement and determination of the ankle-brachial index with variable success. It will be
beneficial to investigate a reliable oscillometric-based procedure that can accurately
measure leg pressures for the ankle-brachial index across the entire spectrum of PAD
severity.
In a previous pilot study completed in 2009 (IRB 08-823), the investigators gathered data
from N=60 subjects which allowed for mathematical analysis of oscillometric waveforms
derived from the lower extremities as compared to Doppler-based measurements of blood
pressure. We used signal processing analysis and regression techniques to develop a two-step
algorithm which will allow for accurate interpretation of oscillometric waveforms in
normal/mild vs. moderate/severely diseased limb and accurate calculation of ankle pressure
across the spectrum of peripheral artery disease severity.
This proposed project will validate this novel oscillometric ABI algorithm in a population
of patients who have been identified as at risk for PAD and for whom screening ABI has been
recommended by multiple professional organizations (AHA/ACC and American Diabetes
Association). Arm, ankle, and toe pressure measurements will be made in the supine position
using Doppler, oscillometric methods, and a photoplethysmographic sensor. The ankle-brachial
index and toe-brachial index will be calculated.
Status | Completed |
Enrollment | 161 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - At least 70 years of age - At least 50 years of age with a history of diabetes mellitus or tobacco smoking (>100 cigarettes in their lifetime) - Ambulatory Outpatient Exclusion Criteria: - Unable to give informed consent - Unable to lie supine for at least 15 minutes - Known non-compressible vessels on prior laboratory studies (ABI>1.3 on either side) |
Observational Model: Cohort, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Summit Doppler Systems, Inc. | The Cleveland Clinic |
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