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NCT00452309 Clinical Trial

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

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00452309
Other study ID # IRB 06-1007
Secondary ID
Status Completed
Phase N/A
First received March 25, 2007
Last updated September 25, 2007
Start date March 2007
Est. completion date August 2007

Study information
Verified date September 2007
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Cleveland Clinic Foundation Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 60 Years and older
Eligibility 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

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
United States Cleveland Clinic Foundation Cleveland Ohio

Sponsors (2)
Lead Sponsor Collaborator
The Cleveland Clinic Summit Doppler Systems, Inc.

Country where clinical trial is conducted

United States, 

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