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Evaluation of Musculoskeletal Microcirculation With Ultrasound (EMMU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02086331
Recruitment Status : Terminated
First Posted : March 13, 2014
Results First Posted : November 25, 2020
Last Update Posted : November 25, 2020
Sponsor:
Information provided by (Responsible Party):
Imperial College London

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.

Condition or disease Intervention/treatment Phase
Standardised Claudication Treadmill Test Procedure: Contrast enhanced ultrasound Behavioral: Treadmill test Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Musculoskeletal Microcirculation With Ultrasound
Actual Study Start Date : December 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: Healthy
Healthy volunteers, deemed to have normal metabolic and cardiovascular biology by trial criteria
Procedure: Contrast enhanced ultrasound
Infusion of microbubbles to enhance blood vessels in the leg for ultrasound

Behavioral: Treadmill test
Exposes you to exercise in a controlled environment. We will see if we can detect this change with our new ultrasound protocol

Procedure: Contrast enhanced ultrasound
Active Comparator: PAD
Symptomatic peripheral arterial disease
Procedure: Contrast enhanced ultrasound
Infusion of microbubbles to enhance blood vessels in the leg for ultrasound

Behavioral: Treadmill test
Exposes you to exercise in a controlled environment. We will see if we can detect this change with our new ultrasound protocol

Procedure: Contrast enhanced ultrasound
Active Comparator: DM
Symptomatic diabetic peripheral neuropathy
Procedure: Contrast enhanced ultrasound
Infusion of microbubbles to enhance blood vessels in the leg for ultrasound

Behavioral: Treadmill test
Exposes you to exercise in a controlled environment. We will see if we can detect this change with our new ultrasound protocol

Procedure: Contrast enhanced ultrasound



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Group 1 - Healthy subjects Inclusion

  • 18+ years old

Exclusion

  • Personal history of diabetes or peripheral arterial disease, current pregnancy, previous surgery to the lower limb, heart attack within 4 weeks, or unstable angina

Group 2 - Peripheral arterial disease subjects Inclusion

  • 18+ years old, radiological evidence of peripheral arterial disease (arterial doppler or angiogram), ankle-brachial pressure index (ABPI) 0.5-0.8

Exclusion

  • Personal history of diabetes, current pregnancy, previous amputation, heart attack within 4 weeks, or unstable angina

Group 3 - Diabetic subjects Inclusion

  • 18+ years old, with a clinical diagnoses of diabetes (1, 2)

Exclusion

- ABPI<0.9, previous amputation, current pregnancy or breastfeeding, heart attack within 4 weeks, or unstable angina.


Information from the National Library of Medicine

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): NCT02086331


Locations
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United Kingdom
Charing Cross Hospital
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Prof AH Davies Imperial College London
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02086331    
Other Study ID Numbers: 13/LO/0943
13HH0684 ( Other Identifier: Imperial College London )
First Posted: March 13, 2014    Key Record Dates
Results First Posted: November 25, 2020
Last Update Posted: November 25, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
treadmill test
Additional relevant MeSH terms:
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Intermittent Claudication
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases