Pilot Study to Determine the Optimal Technique for Measurement of Ankle Blood Pressures

NCT00819598 | Completed

• 1 other identifier: CCF IRB 08-823
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Peripheral arterial disease (PAD) is a highly prevalent medical condition. Patients with PAD are usually diagnosed on the basis of the ankle-brachial index. The ankle-brachial index is the ratio of ankle pressure to arm pressure based on measurement of blood pressures in the arms and legs using a Doppler device. The need for dedicated equipment and trained personnel, along with the time required to perform the test, have been identified as barriers to widespread implementation of ankle-brachial index screening. The use of automated oscillometric devices for blood pressure measurement and determination of the ankle-brachial index has been applied with variable success. It will be beneficial to investigate a reliable oscillometric-based procedure that can accurately measure leg pressures for the ankle-brachial index across the entire spectrum of PAD severity. The purpose of this study is to determine the optimal oscillometric-based technique for estimation of Doppler-derived systolic arm and ankle blood pressures for calculation of the ankle-brachial index in patients with and without PAD. Subjects with suspected arterial disease in the non-invasive lab will be enrolled. Arm, ankle, and toe pressure measurements will be made in the supine position using Doppler, oscillometric methods, and photoplethysmographic sensor. Arm and ankle pressures from a subset of subjects will be obtained in both seated and supine positions. The ankle-brachial index and toe-brachial index will be calculated.

Conditions

Peripheral Arterial Disease

Study Arms (1)

SUSPECTED ARTERIAL DISEASE

Procedure: BLOOD PRESSURE MEASURMENT; Procedure: BLOOD PRESSURE MEASUREMENT

Interventions

BLOOD PRESSURE MEASURMENT PROCEDURE

Blood pressures using Doppler and oscillometric methods will be obtained at each limb and on one toe from each foot.

SUSPECTED ARTERIAL DISEASE

BLOOD PRESSURE MEASUREMENT PROCEDURE

Blood pressure measurements will be taken at each limb (arm and ankle) with Doppler and oscillometric based methods.

SUSPECTED ARTERIAL DISEASE

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to Cleveland Clinic's non-invasive vascular lab

You may qualify if:

• Patient at least 50 years of age
• Ambulatory outpatient
• Referred to non-invasive Vascular Laboratory for evaluation of suspected arterial disease.

You may not qualify if:

• Unable to give informed consent
• Unable to lie supine for at least 15 minutes

Sponsors & Collaborators

• Summit Doppler Systems, Inc.: lead
• The Cleveland Clinic: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Heather L Gornik, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 7, 2009
• First Posted: January 9, 2009
• Study Start: January 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: November 13, 2009

Record last verified: 2009-11

Locations

US (1)