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
  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
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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by The Cleveland Clinic

Additional 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
Study First Received: March 25, 2007
Last Updated: September 25, 2007
Health Authority: United States: Cleveland Clinic Foundation Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 15, 2014