An observational study in Peripheral Arterial Disease, sponsored by Summit Doppler Systems, Inc.. Completed at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-02-24.
Sponsored by Summit Doppler Systems, Inc. · 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.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's planned enrollment of 161 is below the median of 190 across 410 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Summit Doppler Systems, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients presenting to the non-invasive vascular laboratory or another outpatient clinic in the Heart and Vascular Institute at Cleveland Clinic.
Exclusion Criteria:
Patients with known or suspected arterial disease and patients screened using AHA/ACC criteria for P.A.D.
Device: Blood Pressure Measurement
Systolic blood pressures will be obtained from each limb using Doppler, oscillometric, and photoplethysmographic (PPG) modalities.
This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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Summit Doppler Systems, Inc.