Pilot Study to Determine the Optimal Technique for Measurement of Ankle Blood Pressures
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|ClinicalTrials.gov Identifier: NCT00819598|
Recruitment Status : Completed
First Posted : January 9, 2009
Last Update Posted : November 13, 2009
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 or disease||Intervention/treatment|
|Peripheral Arterial Disease||Procedure: BLOOD PRESSURE MEASURMENT Procedure: BLOOD PRESSURE MEASUREMENT|
|Study Type :||Observational|
|Estimated Enrollment :||70 participants|
|Official Title:||Pilot Study to Determine the Optimal Oscillometric-Based Technique for Measurement of Ankle Blood Pressures for the Ankle-brachial Index|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00819598
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Heather L Gornik, MD||The Cleveland Clinic|