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

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Procedure: BLOOD PRESSURE MEASURMENT; Procedure: BLOOD PRESSURE MEASUREMENT

• Registration Number: NCT00819598
• Lead Sponsor: Summit Doppler Systems, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-07
• Study First Submitted QC: 2009-01-08
• Study First Posted: 2009-01-09
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-10
• Last Update Posted: 2009-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SUSPECTED ARTERIAL DISEASE	BLOOD PRESSURE MEASURMENT	-
SUSPECTED ARTERIAL DISEASE	BLOOD PRESSURE MEASUREMENT	-

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States