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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:
ClinicalTrials.gov Identifier:
NCT00452309
First Posted: March 27, 2007
Last Update Posted: September 26, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Summit Doppler Systems, Inc.
Information provided by:
The Cleveland Clinic
  Purpose
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.

Condition
Peripheral Arterial Disease

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Validation of a Correction Factor for Measurement of an Accurate Ankle-Brachial Index in the Seated Position

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Estimated Enrollment: 50
Study Start Date: March 2007
Study Completion Date: August 2007
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.

  Eligibility

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00452309


Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44120
Sponsors and Collaborators
The Cleveland Clinic
Summit Doppler Systems, Inc.
Investigators
Principal Investigator: Heather L Gornik, M.D. The Cleveland Clinic
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00452309     History of Changes
Other Study ID Numbers: IRB 06-1007
First Submitted: March 25, 2007
First Posted: March 27, 2007
Last Update Posted: September 26, 2007
Last Verified: September 2007

Keywords provided by The Cleveland Clinic:
peripheral arterial disease
pad
ankle brachial index
abi

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