Non-Contact Measurement of Aortic Compliance

NCT00987181 | Completed

• 2 other identifiers: II-FS-0109-11005i4i Track 1
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Vascular Disease

Keywords

Pulse wave velocity; Non contact; Non-invasive; Photoplethysmography; Doppler flow velocimetry

Outcome Measures

Primary Outcomes (1)

• 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.

  Single measurement to be made between January 2010 and June 2010

Secondary Outcomes (1)

• Assessment of differences in aPWV and between low and high risk groups of patients undergoing elective coronary angiography.

  Single measurement to be made between January 2010 and June 2010

Study Arms (2)

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.

Angiography Low Risk

Patients with chest pain symptoms, minimal risk factors, and inconclusive evidence of myocardial ischaemia on non-invasive testing.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non-interventional cardiology clinic. Patients undergoing elective angiography.

You may qualify if:

• Age 18 years and above
• Patients eligible for coronary angiography
• Informed consent obtained
• Able to complete experimental protocol

You may not qualify if:

• 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

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

London Chest Hospital

London, London, E2 9JX, United Kingdom

Location

Related Publications (8)

• 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.

  BACKGROUND

• 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.

  PMID: 12214765 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 15867132 BACKGROUND

• Greenwald SE. Ageing of the conduit arteries. J Pathol. 2007 Jan;211(2):157-72. doi: 10.1002/path.2101.

  PMID: 17200940 BACKGROUND

• Mitchell, G.F., Pulse Wave Velocity Measuring Device, USA, 2001, 6331162 B1.

  BACKGROUND

• 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.

  PMID: 18806624 BACKGROUND

• 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.

  PMID: 18786091 BACKGROUND

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Stephen E Greenwald, PhD

  Queen Mary University of London, Barts & The London School of Medicine & Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiovascular Mechanics

Study Record Dates

• First Submitted: September 15, 2009
• First Posted: September 30, 2009
• Study Start: September 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: March 1, 2013
• Last Updated: February 23, 2015

Record last verified: 2015-02

Locations

GB (1)