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

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Single measurement to be made between January 2010 and June 2010

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Single measurement to be made between January 2010 and June 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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.

Clinical Trials on Vascular Disease

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