Pilot Study to Determine the Optimal Technique for Measurement of Ankle Blood Pressures

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study to Determine the Optimal Oscillometric-Based Technique for Measurement of Ankle Blood Pressures for the Ankle-brachial Index

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Procedure: BLOOD PRESSURE MEASURMENT
* Procedure: BLOOD PRESSURE MEASUREMENT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient at least 50 years of age Ambulatory outpatient Referred to non-invasive Vascular Laboratory for evaluation of suspected arterial disease. Exclusion Criteria: Unable to give informed consent Unable to lie supine for at least 15 minutes

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SUSPECTED ARTERIAL DISEASE<br> | Procedure: BLOOD PRESSURE MEASURMENT<br>* Blood pressures using Doppler and oscillometric methods will be obtained at each limb and on one toe from each foot.<br>Procedure: BLOOD PRESSURE MEASUREMENT<br>* Blood pressure measurements will be taken at each limb (arm and ankle) with Doppler and oscillometric based methods.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |