Peripheral Arterial Disease Clinical Trial
Official title:
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.
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Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional
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