Non-Contact Measurement of Aortic Compliance

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Barts & The London NHS Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by:
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT00987181
First received: September 15, 2009
Last updated: February 21, 2011
Last verified: February 2011
  Purpose

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).


Condition
Vascular Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Non Contact Measurement of Aortic Pulse Wave Velocity

Resource links provided by NLM:


Further study details as provided by Barts & The London NHS Trust:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2010
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Non-interventional cardiology clinic. Patients undergoing elective angiography.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00987181

Contacts
Contact: Martin T Rothman, MBChB +44 20 8983 2216 martin.rothman@bartsandthelondon.nhs.uk
Contact: Ajay K Jain, MBBS +44 20 8983 2216 aj.k.jain@googlemail.com

Locations
United Kingdom
London Chest Hospital Not yet recruiting
London, United Kingdom, E2 9JX
Contact: Martin T Rothman, MBChB    +44 20 8983 2216    martin.rothman@bartsandthelondon.nhs.uk   
Contact: Ajaj K Jain, MBBS    +44 20 8983 2216    aj.k.jain@googlemail.com   
Principal Investigator: Martin T Rothman, MBChB         
Sub-Investigator: Ajay K Jain, MBBS         
Sponsors and Collaborators
Barts & The London NHS Trust
National Institute for Health Research, United Kingdom
Investigators
Principal Investigator: Stephen E Greenwald, PhD Queen Mary University of London, Barts & The London School of Medicine & Dentistry
  More Information

Publications:
Responsible Party: Prof. Stephen Greenwald, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT00987181     History of Changes
Other Study ID Numbers: II-FS-0109-11005, i4i Track 1
Study First Received: September 15, 2009
Last Updated: February 21, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by Barts & The London NHS Trust:
Pulse wave velocity
Non contact
Non-invasive
Photoplethysmography
Doppler flow velocimetry

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014