Pilot Study to Determine the Optimal Technique for Measurement of Ankle Blood Pressures
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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 |
| 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 |
Patients presenting to Cleveland Clinic's non-invasive vascular lab
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| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| 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 May 23, 2013