Back to resultsEvaluation of Musculoskeletal Microcirculation With Ultrasound (EMMU)
Primary Purpose
Standardised Claudication Treadmill Test
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Contrast enhanced ultrasound
Treadmill test
Contrast enhanced ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Standardised Claudication Treadmill Test focused on measuring treadmill test
Eligibility 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.
Sites / Locations
- Charing Cross Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Healthy
PAD
DM
Arm Description
Healthy volunteers, deemed to have normal metabolic and cardiovascular biology by trial criteria
Symptomatic peripheral arterial disease
Symptomatic diabetic peripheral neuropathy
Outcomes
Primary Outcome Measures
Threshold of High to Low Frequency Ratio (Threshold HLFR)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02086331
First Posted
January 9, 2014
Last Updated
November 2, 2020
Sponsor
Imperial College London
1. Study Identification
Unique Protocol Identification Number
NCT02086331
Brief Title
Evaluation of Musculoskeletal Microcirculation With Ultrasound
Acronym
EMMU
Official Title
Evaluation of Musculoskeletal Microcirculation With Ultrasound
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Study Start Date
December 2013 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Standardised Claudication Treadmill Test
Keywords
treadmill test
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy
Arm Type
Active Comparator
Arm Description
Healthy volunteers, deemed to have normal metabolic and cardiovascular biology by trial criteria
Arm Title
PAD
Arm Type
Active Comparator
Arm Description
Symptomatic peripheral arterial disease
Arm Title
DM
Arm Type
Active Comparator
Arm Description
Symptomatic diabetic peripheral neuropathy
Intervention Type
Procedure
Intervention Name(s)
Contrast enhanced ultrasound
Intervention Description
Infusion of microbubbles to enhance blood vessels in the leg for ultrasound
Intervention Type
Behavioral
Intervention Name(s)
Treadmill test
Intervention Description
Exposes you to exercise in a controlled environment. We will see if we can detect this change with our new ultrasound protocol
Intervention Type
Procedure
Intervention Name(s)
Contrast enhanced ultrasound
Primary Outcome Measure Information:
Title
Threshold of High to Low Frequency Ratio (Threshold HLFR)
Description
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.
Time Frame
Baseline, 20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof AH Davies
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of Musculoskeletal Microcirculation With Ultrasound
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