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

This study has been completed.
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by:
Summit Doppler Systems, Inc.
ClinicalTrials.gov Identifier:
NCT00819598
First received: January 7, 2009
Last updated: November 10, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention
Peripheral Arterial Disease
Procedure: BLOOD PRESSURE MEASURMENT
Procedure: BLOOD PRESSURE MEASUREMENT

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Study to Determine the Optimal Oscillometric-Based Technique for Measurement of Ankle Blood Pressures for the Ankle-brachial Index

Resource links provided by NLM:


Further study details as provided by Summit Doppler Systems, Inc.:

Estimated Enrollment: 70
Study Start Date: January 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
SUSPECTED ARTERIAL DISEASE Procedure: BLOOD PRESSURE MEASURMENT
Blood pressures using Doppler and oscillometric methods will be obtained at each limb and on one toe from each foot.
Procedure: BLOOD PRESSURE MEASUREMENT
Blood pressure measurements will be taken at each limb (arm and ankle) with Doppler and oscillometric based methods.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819598

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Summit Doppler Systems, Inc.
The Cleveland Clinic
Investigators
Principal Investigator: Heather L Gornik, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Dr. Heather Gornik, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00819598     History of Changes
Other Study ID Numbers: CCF IRB 08-823
Study First Received: January 7, 2009
Last Updated: November 10, 2009
Health Authority: United States: Institutional Review Board

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 16, 2014