- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00987181
Non-Contact Measurement of Aortic Compliance
February 20, 2015 updated by: Stephen Greenwald, Barts & The London NHS Trust
Non Contact Measurement of Aortic Pulse Wave Velocity
Reduced aortic stiffness is a powerful way to predict the outcome of cardiovascular (CV) disease.
There are several non invasive methods for its estimation, most of which are based on the measurement of speed of the arterial pulse wave.
(The stiffer the artery, the faster the pulse wave travels.)
They rely on detecting the arterial pulse with 2 sensors placed on the skin a known distance apart and measuring the time for the pulse to travel between them.
However all current methods require skilled operators and are of limited accuracy.
Thus, there is a need for an easy to use and reliable device to measure pulse speed.
The aim of this project is to develop a non contact device to detect the aortic pulse as it moves into the small arteries following the ribs, using the principle of thermal imaging, by means of a high sensitivity infra red camera, directed towards the subjects back.
The investigators plan to validate the device and conduct a small feasibility study in patients undergoing elective angiography, by simultaneously measuring pulse speed using established methods.
These are Doppler ultrasound (non-invasive) and direct intra-arterial measurement (the gold standard).
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, E2 9JX
- London Chest Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Non-interventional cardiology clinic.
Patients undergoing elective angiography.
Description
Inclusion Criteria:
- Age 18 years and above
- Patients eligible for coronary angiography
- Informed consent obtained
- Able to complete experimental protocol
Exclusion Criteria:
- Refusal of consent
- Age below 18 years
- Breast feeding
- Known or suspected pregnancy
- Patient participating in another study at time of study entry or previous participation in this registry
- diagnosed but untreated hypertension
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Angiography high risk
Patients with multiple risk factors, positive non-invasive test, or known pre-existing coronary artery/vascular disease.
Patients with diabetes mellitus will be identified, and subject to a sub-group analysis.
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Angiography Low Risk
Patients with chest pain symptoms, minimal risk factors, and inconclusive evidence of myocardial ischaemia on non-invasive testing.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Quantitative agreement between intra-arterial measurement of aortic pulse wave velocity and transcutaneous values: a) Contact PPG from probes on the skin of the back in the intercostal spaces and b) non-contact from infra-red camera imaging the back.
Time Frame: Single measurement to be made between January 2010 and June 2010
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Single measurement to be made between January 2010 and June 2010
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Assessment of differences in aPWV and between low and high risk groups of patients undergoing elective coronary angiography.
Time Frame: Single measurement to be made between January 2010 and June 2010
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Single measurement to be made between January 2010 and June 2010
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephen E Greenwald, PhD, Queen Mary University of London, Barts & The London School of Medicine & Dentistry
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wang X, Keith JC Jr, Struthers AD, Feuerstein GZ. Assessment of arterial stiffness, a translational medicine biomarker system for evaluation of vascular risk. Cardiovasc Ther. 2008 Fall;26(3):214-23. doi: 10.1111/j.1755-5922.2008.00051.x.
- Cohn JN, Duprez DA, Grandits GA. Arterial elasticity as part of a comprehensive assessment of cardiovascular risk and drug treatment. Hypertension. 2005 Jul;46(1):217-20. doi: 10.1161/01.HYP.0000165686.50890.c3. Epub 2005 May 2.
- Greenwald, S.E., Denyer, H.T., and Sobeh, M.S., Non Invasive Measurement of Vascular Compliance by a Photoplethysmographic Technique. SPIE Proc., 1997. 2970: 89-97.
- Loukogeorgakis S, Dawson R, Phillips N, Martyn CN, Greenwald SE. Validation of a device to measure arterial pulse wave velocity by a photoplethysmographic method. Physiol Meas. 2002 Aug;23(3):581-96. doi: 10.1088/0967-3334/23/3/309.
- Zheng, J., Hu., S., Azorin-Peris, V., Echiadis, A., Shi, P., Chouliaras, V., "A remote approach to measure blood perfusion from the human face", Vol. 7170. 7170-4., Proc. of SPIE BiOS
- Greenwald SE. Ageing of the conduit arteries. J Pathol. 2007 Jan;211(2):157-72. doi: 10.1002/path.2101.
- Mitchell, G.F., Pulse Wave Velocity Measuring Device, USA, 2001, 6331162 B1.
- Rajzer MW, Wojciechowska W, Klocek M, Palka I, Brzozowska-Kiszka M, Kawecka-Jaszcz K. Comparison of aortic pulse wave velocity measured by three techniques: Complior, SphygmoCor and Arteriograph. J Hypertens. 2008 Oct;26(10):2001-7. doi: 10.1097/HJH.0b013e32830a4a25.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
September 15, 2009
First Submitted That Met QC Criteria
September 29, 2009
First Posted (Estimate)
September 30, 2009
Study Record Updates
Last Update Posted (Estimate)
February 23, 2015
Last Update Submitted That Met QC Criteria
February 20, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- II-FS-0109-11005
- i4i Track 1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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