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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014