Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452309
Status:
COMPLETED
Last Update Posted:
2007-09-26
First Post:
2007-03-25
Brief Title:
Validation of a Correction Factor for Measurement of an Accurate Ankle-Brachial Index in the Seated Position
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Validation of a Correction Factor for Measurement of an Accurate Ankle-Brachial Index in the Seated Position
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None