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

NCT ID: NCT01165437

Last Updated: 2011-02-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 161 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-01-31

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 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.

Conditions

Peripheral Arterial Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Suspected Arterial Disease

Patients with known or suspected arterial disease and patients screened using AHA/ACC criteria for P.A.D.

Blood Pressure Measurement

Intervention Type: DEVICE

Systolic blood pressures will be obtained from each limb using Doppler, oscillometric, and photoplethysmographic (PPG) modalities.

Interventions

Blood Pressure Measurement

Systolic blood pressures will be obtained from each limb using Doppler, oscillometric, and photoplethysmographic (PPG) modalities.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

Summit Doppler Systems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Summit Doppler Systems, Inc.

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CCF IRB 10-513

Identifier Type: -

Identifier Source: org_study_id