NCT02086331

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 9, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
5 years until next milestone

Results Posted

Study results publicly available

November 25, 2020

Completed
Last Updated

November 25, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

January 9, 2014

Results QC Date

October 5, 2020

Last Update Submit

November 2, 2020

Conditions

Standardised Claudication Treadmill Test

Keywords

treadmill test

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 20 minutes

Study Arms (3)

Healthy

ACTIVE COMPARATOR

Healthy volunteers, deemed to have normal metabolic and cardiovascular biology by trial criteria

Procedure: Contrast enhanced ultrasoundBehavioral: Treadmill test

PAD

ACTIVE COMPARATOR

Symptomatic peripheral arterial disease

Procedure: Contrast enhanced ultrasoundBehavioral: Treadmill test

DM

ACTIVE COMPARATOR

Symptomatic diabetic peripheral neuropathy

Procedure: Contrast enhanced ultrasoundBehavioral: Treadmill test

Interventions

Contrast enhanced ultrasoundPROCEDURE

Infusion of microbubbles to enhance blood vessels in the leg for ultrasound

DMHealthyPAD
Treadmill testBEHAVIORAL

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

DMHealthyPAD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Personal history of diabetes or peripheral arterial disease, current pregnancy, previous surgery to the lower limb, heart attack within 4 weeks, or unstable angina
  • + years old, radiological evidence of peripheral arterial disease (arterial doppler or angiogram), ankle-brachial pressure index (ABPI) 0.5-0.8
  • Personal history of diabetes, current pregnancy, previous amputation, heart attack within 4 weeks, or unstable angina
  • + years old, with a clinical diagnoses of diabetes (1, 2)
  • \- ABPI\<0.9, previous amputation, current pregnancy or breastfeeding, heart attack within 4 weeks, or unstable angina.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

MeSH Terms

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Results Point of Contact

Title
Miss Kate Williams
Organization
Imperial College London
k.williams@imperial.ac.uk

Study Officials

  • Prof AH Davies

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2014

First Posted

March 13, 2014

Study Start

December 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 25, 2020

Results First Posted

November 25, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)