Validation of a Novel Oscillometric-Based Algorithm for Determination of the Ankle-Brachial Index

Peripheral Arterial Disease Clinical Trial

Official title:

Validation of a Novel Oscillometric-Based Algorithm for Determination of the Ankle-Brachial Index

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01165437
• Other study ID #: CCF IRB 10-513
• Status: Completed
• Phase: N/A
• First received: July 15, 2010
• Last updated: February 22, 2011
• Start date: October 2010
• Est. completion date: January 2011

Study information

• Verified date: February 2011
• Source: Summit Doppler Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• 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 after 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 has been applied to leg pressure measurement and determination of the ankle-brachial index 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.

In a previous pilot study completed in 2009 (IRB 08-823), the investigators gathered data from N=60 subjects which allowed for mathematical analysis of oscillometric waveforms derived from the lower extremities as compared to Doppler-based measurements of blood pressure. We used signal processing analysis and regression techniques to develop a two-step algorithm which will allow for accurate interpretation of oscillometric waveforms in normal/mild vs. moderate/severely diseased limb and accurate calculation of ankle pressure across the spectrum of peripheral artery disease severity.

This proposed project will validate this novel oscillometric ABI algorithm in a population of patients who have been identified as at risk for PAD and for whom screening ABI has been recommended by multiple professional organizations (AHA/ACC and American Diabetes Association). Arm, ankle, and toe pressure measurements will be made in the supine position using Doppler, oscillometric methods, and a photoplethysmographic sensor. The ankle-brachial index and toe-brachial index will be calculated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• At least 70 years of age

• At least 50 years of age with a history of diabetes mellitus or tobacco smoking (>100 cigarettes in their lifetime)

• Ambulatory Outpatient

Exclusion Criteria:

• Unable to give informed consent

• Unable to lie supine for at least 15 minutes

• Known non-compressible vessels on prior laboratory studies (ABI>1.3 on either side)

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Blood Pressure Measurement
Systolic blood pressures will be obtained from each limb using Doppler, oscillometric, and photoplethysmographic (PPG) modalities.

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,