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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00819598
• Other study ID #: CCF IRB 08-823
• Status: Completed
• Phase: N/A
• First received: January 7, 2009
• Last updated: November 10, 2009
• Start date: January 2009
• Est. completion date: October 2009

Study information

• Verified date: November 2009
• Source: Summit Doppler Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Procedure:
• BLOOD PRESSURE MEASURMENT
Blood pressures using Doppler and oscillometric methods will be obtained at each limb and on one toe from each foot.
• BLOOD PRESSURE MEASUREMENT
Blood pressure measurements will be taken at each limb (arm and ankle) with Doppler and oscillometric based methods.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Summit Doppler Systems, Inc.	The Cleveland Clinic

Country where clinical trial is conducted

United States,