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

NCT ID: NCT00819598

Last Updated: 2009-11-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-10-31

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 Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

SUSPECTED ARTERIAL DISEASE

BLOOD PRESSURE MEASURMENT

Intervention Type: PROCEDURE

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

BLOOD PRESSURE MEASUREMENT

Intervention Type: PROCEDURE

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

Interventions

BLOOD PRESSURE MEASURMENT

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

Intervention Type: PROCEDURE

BLOOD PRESSURE MEASUREMENT

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patient at least 50 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

Summit Doppler Systems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Cleveland Clinic

Principal Investigators

Heather L Gornik, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CCF IRB 08-823

Identifier Type: -

Identifier Source: org_study_id