Pilot Study to Determine the Optimal Technique for Measurement of Ankle Blood Pressures
Completed
Conditions studied: Peripheral Arterial Disease
In brief
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 based on 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 and determination of the ankle-brachial index has been applied 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. The purpose of this study is to determine the optimal oscillometric-based technique for estimation of Doppler-derived systolic arm and ankle blood pressures for calculation of the ankle-brachial index in patients with and without PAD. Subjects with suspected arterial disease in the non-invasive lab will be enrolled. Arm, ankle, and toe pressure measurements will be made in the supine position using Doppler, oscillometric methods, and photoplethysmographic sensor. Arm and ankle pressures from a subset of subjects will be obtained in both seated and supine positions. The ankle-brachial index and toe-brachial index will be calculated.
Key facts
- Study ID
- NCT00819598
- Run by
- Summit Doppler Systems, Inc.
- People needed
- 70
- Starts
- 2009-01-01
- Expected to finish
- 2009-10-01
- Last updated by the study team
- 2009-11-13
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Patient at least 50 years of age
- Ambulatory outpatient
- Referred to non-invasive Vascular Laboratory for evaluation of suspected arterial disease.
You may not qualify if…
- Unable to give informed consent
- Unable to lie supine for at least 15 minutes
Where it is running
- Cleveland Clinic — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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