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Validation of a Correction Factor for Measurement of an Accurate Ankle-Brachial Index in the Seated Position

This study has been completed.
Sponsor:
Collaborator:
Summit Doppler Systems, Inc.
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00452309
First received: March 25, 2007
Last updated: September 25, 2007
Last verified: September 2007
History of Changes

March 25, 2007
September 25, 2007
March 2007
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Complete list of historical versions of study NCT00452309 on ClinicalTrials.gov Archive Site
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Validation of a Correction Factor for Measurement of an Accurate Ankle-Brachial Index in the Seated Position
Validation of a Correction Factor for Measurement of an Accurate Ankle-Brachial Index in the Seated Position

The purpose of this study is to test a correction factor which would allow ankle brachial indexes taken in the seated position to accurately predict an ankle brachial index taken in the supine position.

Peripheral arterial disease (PAD) is a highly prevalent medical condition. Patients with PAD are usually diagnosed on the basis of a simple diagnostic procedure know as the ankle-brachial index (ABI). The ABI is the ratio of ankle pressure to arm pressure after measurement of blood pressures in the arms and legs using a hand-held Doppler device. In order for the ABI measurement to be accurate, the test is conducted with the patient in the supine position. This eliminates the influence of hydrostatic pressure on the ankle and toes which can lead to a falsely elevated reading. Unfortunately, many patients are unable to lie supine for ABI measurement, including: the wheel-chair bound, patients with degenerative disease of the spine or arthritis with chronic back pain, and patients with advanced cardiopulmonary disease and orthopnea.

Given the importance of detecting PAD across a broad spectrum of patients, there is a need to identify a mechanism for reliable measurement of the ABI for patients who cannot lie supine. The purpose of this study is to test a correction factor for the effects of hydrostatic pressure on the lower extremities to allow for accurate ABI calculation in the seated position.

100 Subjects with suspected arterial disease in the vascular lab will be enrolled. Arm, ankle, and toe pressure measurements will be made in the supine and seated positions. The seated ankle pressures will be corrected for hydrostatic pressure using a mechanical formula. The ABI and toe brachial index (TBI) will be calculated.
Observational
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
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Peripheral Arterial Disease
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Gornik HL, Garcia B, Wolski K, Jones DC, Macdonald KA, Fronek A. Validation of a method for determination of the ankle-brachial index in the seated position. J Vasc Surg. 2008 Nov;48(5):1204-10. Epub 2008 Sep 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
August 2007
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Inclusion Criteria:

  • Patient at least 60 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
Both
60 Years and older
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00452309
IRB 06-1007
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The Cleveland Clinic
Summit Doppler Systems, Inc.
Principal Investigator: Heather L Gornik, M.D. The Cleveland Clinic
The Cleveland Clinic
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP