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

This study has been completed.
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by:
Summit Doppler Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01165437
First received: July 15, 2010
Last updated: February 22, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Peripheral Arterial Disease
Device: Blood Pressure Measurement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Validation of a Novel Oscillometric-Based Algorithm for Determination of the Ankle-Brachial Index

Resource links provided by NLM:


Further study details as provided by Summit Doppler Systems, Inc.:

Estimated Enrollment: 161
Study Start Date: October 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Suspected Arterial Disease
Patients with known or suspected arterial disease and patients screened using AHA/ACC criteria for P.A.D.
Device: Blood Pressure Measurement
Systolic blood pressures will be obtained from each limb using Doppler, oscillometric, and photoplethysmographic (PPG) modalities.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients presenting to the non-invasive vascular laboratory or another outpatient clinic in the Heart and Vascular Institute at Cleveland Clinic.

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01165437

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Summit Doppler Systems, Inc.
The Cleveland Clinic
  More Information

No publications provided

Responsible Party: David C. Jones, Summit Doppler Systems, Inc.
ClinicalTrials.gov Identifier: NCT01165437     History of Changes
Other Study ID Numbers: CCF IRB 10-513
Study First Received: July 15, 2010
Last Updated: February 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Summit Doppler Systems, Inc.:
Peripheral
Arterial
Vascular

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014