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

S

Summit Doppler Systems

Status

Completed

Conditions

Peripheral Arterial Disease

Treatments

Procedure: BLOOD PRESSURE MEASUREMENT
Procedure: BLOOD PRESSURE MEASURMENT

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT00819598
CCF IRB 08-823

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

70 participants in 1 patient group

SUSPECTED ARTERIAL DISEASE
Treatment:
Procedure: BLOOD PRESSURE MEASUREMENT
Procedure: BLOOD PRESSURE MEASURMENT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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