Non-Contact Measurement of Aortic Compliance

Vascular Disease Clinical Trial

Official title:

Non Contact Measurement of Aortic Pulse Wave Velocity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987181
• Other study ID #: II-FS-0109-11005
• Secondary ID: i4i Track 1
• Status: Completed
• Phase: N/A
• First received: September 15, 2009
• Last updated: February 20, 2015
• Start date: September 2010
• Est. completion date: March 2013

Study information

• Verified date: February 2015
• Source: Barts & The London NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Vascular Disease
• Vascular Diseases

Locations

Country	Name	City	State
United Kingdom	London Chest Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Barts & The London NHS Trust	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

References & Publications (8)

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. Epub 2005 May 2. Review. — View Citation

Greenwald SE. Ageing of the conduit arteries. J Pathol. 2007 Jan;211(2):157-72. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No