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Clinical Trials/NCT02086331
NCT02086331
Terminated
Not Applicable

Evaluation of Musculoskeletal Microcirculation With Ultrasound

Imperial College London1 site in 1 country5 target enrollmentDecember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Standardised Claudication Treadmill Test
Sponsor
Imperial College London
Enrollment
5
Locations
1
Primary Endpoint
Threshold of High to Low Frequency Ratio (Threshold HLFR)
Status
Terminated
Last Updated
5 years ago

Overview

Brief Summary

This study aims to validate the use of Dynamic Contrast-Enhanced Ultrasound in measuring the blood supply to the muscles of the leg, and how this changes with exercise and vascular pathology.

Detailed Description

We propose a model for the use of Dynamic Contrast-Enhanced Ultrasound (DCEU) to directly evaluate the microcirculation of the musculoskeletal system. We believe that this will be a valuable research tool into diseases of the microcirculation, and in the future may also offer a clinical benefit by quantifying and monitoring disease over time and after intervention. It may also allow targeting of therapies towards those patients most at risk of ulcers and peripheral neuropathy, and those that would get the maximum benefit from these therapies.

Registry
clinicaltrials.gov
Start Date
December 2013
End Date
December 2015
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Threshold of High to Low Frequency Ratio (Threshold HLFR)

Time Frame: Baseline, 20 minutes

Please see published article for in depth method. This ratio is used to classify a given signal as either microbubble or noise. For a pixel containing a micro vessel, as microbubbles occasionally pass this otherwise dark pixel, its temporal signal is expected to have a higher proportion of lower frequency components than white noise. Consequently, the HLFR of the pixel is expected to be smaller than that of noise. A histogram of normalised HLFR shows two expected peaks (one noise, one bubbles). A threshold (Threshold HLFR) is determined to then separate the two peaks. this is done using a double Gaussian model, and where they intercept is deemed the Threshold HLFR.

Study Sites (1)

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