Vascular DiseaseNCT00987181
Non-Contact Measurement of Aortic Compliance
An observational study of Vascular Disease, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Disease
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-interventional cardiology clinic. Patients undergoing elective angiography.
Who may be able to join
- Age 18 years and above
- Patients eligible for coronary angiography
- Informed consent obtained
- Able to complete experimental protocol
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Vascular Disease
- Keywords
- Pulse wave velocity, Non contact, Non-invasive, Photoplethysmography, Doppler flow velocimetry
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Single measurement to be made between January 2010 and June 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startSep 2010
- Primary completionJun 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Principal investigator, Stephen Greenwald, Barts & The London NHS Trust
- Investigators
- Stephen E Greenwald, PhD, Principal investigator, Queen Mary University of London, Barts & The London School of Medicine & Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987181
- Sponsor's protocol ID
- II-FS-0109-11005
- Other IDs
- i4i Track 1
- Status last verified
- Feb 2015
- First submitted
- 15 Sep 2009
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12214765Zheng, 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
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.
PubMed 15867132Greenwald SE. Ageing of the conduit arteries. J Pathol. 2007 Jan;211(2):157-72. doi: 10.1002/path.2101.
PubMed 17200940Mitchell, 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.
PubMed 18806624Wang 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.
PubMed 18786091
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Contact Measurement of Aortic Pulse Wave Velocity
- ClinicalTrials.gov ID
- NCT00987181
- Acronym / sponsor ID
- II-FS-0109-11005
- Conditions
- Vascular Disease
- Keywords
- Pulse wave velocity, Non contact, Non-invasive, Photoplethysmography, Doppler flow velocimetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Sep 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 30 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-interventional cardiology clinic. Patients undergoing elective angiography.
Key inclusion criteria (4 listed)
- Age 18 years and above
- Patients eligible for coronary angiography
- Informed consent obtained
- Able to complete experimental protocol
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
- BackgroundGreenwald, 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: PubMed 12214765Loukogeorgakis 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.
- BackgroundZheng, 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: PubMed 15867132Cohn 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.
- Background: PubMed 17200940Greenwald SE. Ageing of the conduit arteries. J Pathol. 2007 Jan;211(2):157-72. doi: 10.1002/path.2101.
- BackgroundMitchell, G.F., Pulse Wave Velocity Measuring Device, USA, 2001, 6331162 B1.
- Background: PubMed 18806624Rajzer 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.
- Background: PubMed 18786091Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen E Greenwald, PhD principal investigator
Queen Mary University of London, Barts & The London School of Medicine & Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Disease, run by Barts & The London NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00987181, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2015.