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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00452309
Enrollment
50
Registered
2007-03-27
Start date
2007-03-31
Completion date
2007-08-31
Last updated
2007-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Keywords

peripheral arterial disease, pad, ankle brachial index, abi

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Summit Doppler Systems, Inc.
CollaboratorINDUSTRY
The Cleveland Clinic
Lead SponsorOTHER

Study design

Observational model
DEFINED_POPULATION
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026