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NCT01165437 · ClinicalTrials.gov registry record
Validation of a Novel Oscillometric-Based Algorithm for Determination of the Ankle-Brachial Index
A clinical trial of Peripheral Arterial Disease, sponsored by Summit Doppler Systems.
- Completed
- Registry status
- 161
- Enrollment target
- 1
- Study location
NCT01165437: Completed study of Peripheral Arterial Disease, sponsored by Summit Doppler Systems.
NCT01165437 is a study of Peripheral Arterial Disease that has completed, run by Summit Doppler Systems. The registered enrollment target is 161 participants, below the 4,204-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01165437, a study of Peripheral Arterial Disease, has completed, sponsored by Summit Doppler Systems.
- COMPLETED
- Registry status
- 161 participants
- Enrollment target
- 1
- Study location
Study Summary
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 after 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 has been applied to leg pressure measurement and determination of the ankle-brachial index 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. In a previous pilot study completed in 2009 (IRB 08-823), the investigators gathered data from N=60 subjects which allowed for mathematical analysis of oscillometric waveforms derived from the lower extremities as compared to Doppler-based measurements of blood pressure. We used signal processing analysis and regression techniques to develop a two-step algorithm which will allow for accurate interpretation of oscillometric waveforms in normal/mild vs. moderate/severely diseased limb and accurate calculation of ankle pressure across the spectrum of peripheral artery disease severity. This proposed project will validate this novel oscillometric ABI algorithm in a population of patients who have been identified as at risk for PAD and for whom screening ABI has been recommended by multiple professional organizations (AHA/ACC and American Diabetes Association). Arm, ankle, and toe pressure measurements will be made in the supine position using Doppler, oscillometric methods, and a photoplethysmographic sensor. The ankle-brachial index and toe-brachial index will be calculated.
Conditions Studied
Interventions
- DEVICE Blood Pressure Measurement
Study Locations (1)
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-01 |
What the finished NCT01165437 record still lists
NCT01165437 is an observational study that tracks outcomes without assigning an intervention. The registered 161 participants enrollment target is mid-sized for trials with a published cap, below the 4,204-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 1 intervention - of which Blood Pressure Measurement is the first listed.
NCT01165437 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT01165437 about?
NCT01165437 is a clinical study titled "Validation of a Novel Oscillometric-Based Algorithm for Determination of the Ankle-Brachial Index". 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 after measurement of blood pressures in the arms and legs using a Doppl...
What is the current status of trial NCT01165437?
This trial is currently completed. The enrollment target is 161 participants. The study started on 2010-10. Estimated completion is 2011-01.
What conditions does trial NCT01165437 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease.
What interventions are being tested in trial NCT01165437?
The interventions under investigation include: Blood Pressure Measurement (DEVICE).
Who is sponsoring clinical trial NCT01165437?
This trial is sponsored by Summit Doppler Systems, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01165437 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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