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Clinical Trials/NCT00819598
NCT00819598
Completed
Not Applicable

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

Summit Doppler Systems, Inc.1 site in 1 country70 target enrollmentJanuary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Arterial Disease
Sponsor
Summit Doppler Systems, Inc.
Enrollment
70
Locations
1
Status
Completed
Last Updated
16 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
October 2009
Last Updated
16 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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