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

NCT00819598 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2009-11-13

No results posted yet for this study

Summary

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.

Conditions

  • Peripheral Arterial Disease

Interventions

PROCEDURE

BLOOD PRESSURE MEASURMENT

Blood pressures using Doppler and oscillometric methods will be obtained at each limb and on one toe from each foot.

PROCEDURE

BLOOD PRESSURE MEASUREMENT

Blood pressure measurements will be taken at each limb (arm and ankle) with Doppler and oscillometric based methods.

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • Summit Doppler Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Heather L Gornik, MD · The Cleveland Clinic

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00819598 on ClinicalTrials.gov