PADPWViNCT03516383
Pulse Wave Velocity Imaging in the Assessment of PAD
An observational study of PAD and Optical Imaging, run by Unity Health Toronto.
Trial summary
The purpose of this study is to predict the outcome of peripheral revascularization surgery by use of a new technology developed by our team, Pulse Wave Velocity imaging (PWVI), which has the capability to detect pulse transit time (PTT), and pulse wave velocity (PWV). Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- PAD, Optical Imaging
- What is being tested?
- PWVi
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2017
- 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Group 1 (n=10), the control group, will be recruited via referral from our research team and will consist of healthy individuals with a normal ABI of 0.9 < ABI < 1.2. Group 2 (n=10), participants with PAD, ABI < 0.6, either requiring revascularization surgery (group 2B, n=5), or not (group 2A, n=5). These participants will be recruited from the population routinely seen by the Principal Investigators or team members.
Who may be able to join
- ABI of 0.9 < ABI < 1.2
- 50 - 90 years of age
- Participants who understand the study and are able to give consent
- Participants who can be followed by the same investigating team for the whole period of their participation in the study Group 2. Experimental (n=10)
- ABI < 0.6, confirmed PAD
- 50 - 90 years of age
Show all 9Show fewer
- In-patients or out-patients
- Participants who understand the study and are able to give consent
- Participants who can be followed by the same investigating team for the whole period of their participation in the study
Who cannot join
- Diabetics
- Smokers
- Body mass index (BMI) > 35 Group 2. Experimental (n=10)
- Diabetics
- Smokers
- Advanced lymphedema or dermatoliposclerosis
- BMI > 35
About this study
The purpose of this study is to predict the outcome of peripheral revascularization surgery by use of a new technology developed by our team, Pulse Wave Velocity imaging (PWVI), which has the capability to detect pulse transit time (PTT), and pulse wave velocity (PWV). This PWVI will be compared against known gold standards pre and post lower extremity limb revascularization and used to evaluate outcomes. Specifically, is leg PWV different among those with or without PAD, and is leg PWV different among those who undergo revascularization surgery and those who do not? This study represents the first clinical pilot study of the device with the aim to expand study participant numbers in future research and to eventually develop a PAD screening tool. This would be the first of its kind ever described.
Read the detailed description
Peripheral artery disease (PAD) is the narrowing of arteries in the extremities, resulting in insufficient blood supply to tissue in the extremities. In its mildest form, PAD may be asymptomatic, or may show mild symptoms such as intermittent claudication (IC), a pain one may experience while walking. [Hirsch et al, 2006; Criqui et al, 1992; Beckman, 2002] At its extreme, PAD may lead to critical limb ischaemia (CLI), necrosis, gangrene, amputation, or even death. [Hirsch et al, 2006; Hirsch et al, 2001; Criqui et al, 1992] PAD affects over 20% of all patients aged 70 and above, or aged 50 to 69 with a history of smoking or diabetes. [Hirsch et al, 2001; Beckman et al, 2006] In primary care, the ankle-brachial index (ABI) has been used as a screening tool for PAD. [Aboyans et al., 2012] The ABI consists of the ratio of systolic blood pressures measured at the ankle to that of the brachial artery. An ABI of 0.9 - 1.1 is considered normal, and ABI ≤ 0.9 is considered abnormal. [Aboyans et al., 2012; Hirsch et al., 2001] By way of the ABI, a primary care practitioner may be able to diagnose PAD with a high degree of specificity (up to 99%), but sensitivity can vary greatly (15-79%). [Xu et al, 2010] More recently, the use of the brachial-ankle pulse wave velocity (baPWV) has been used as another diagnostic tool with regards to coronary artery disease (CAD). [Katakami et al., 2014; Chae et al., 2013; Yamashina et al., 2002] Sugawara et al. have shown that the variability in the baPWV is due 58% to aortic pulse wave velocity (PWV), and 23% to leg PWV. [Sugawara et al., 2005] Although aortic stiffness is a larger component of the baPWV, numerous studies have shown that there is a correlation between baPWV and PAD. [Yokoyama et al., 2003; Amoh-Tonto et al., 2009; Xu et al., 2008] Additionally, it has been shown that baPWV can increase after percutaneous transluminal angioplasty in the lower extremities. [Yokoyama et al., 2003] In context with CLI, although methods of diagnosis have improved over the past decades, amputation rates have seen an increase. [Beckman, 2007] Revascularization surgery has been shown to increase ambulatory function and quality of life in those affected by CLI as compared to those who had undergone amputation. [Brosi et al., 2007; Deneuville \& Perrouillet, 2006; Oresanya et al, 2015] This, and the cut-off ABI value <0.95 set by Motobe et al. in 2005 for the accuracy of baPWV measurements, requires further investigation into leg PWV for a better understanding of PAD and CLI and the effects revascularization surgery has. [Wohlfart et al., 2013] The investigators believe that the ability to determine the success of revascularization surgery at the time of surgery would guide vascular surgeons in the intra-operative treatment and monitoring of these patients. The current standard of care is Doppler of the dorsalis pedis or posterior tibial artery post-operatively and at the bedside. This is not always an accurate determinate of the success of a revascularized limb and subsequently patients require either Duplex ultrasound, computed tomography angiography (CTA) or angiography. The results from these more sophisticated investigations provide accurate information about blood flow and its characteristics. Our group has designed a device called Pulse Wave Velocity imaging (PWVI). This device has the capacity to determine pulse wave velocity, pulse transit time and a waveform analysis at the bedside and can be designed as a small handheld tool. This is essentially a culmination of the information obtained from Duplex ultrasound and photoplethysmography but can be acquired within 30 seconds in any environment (eg. Operating room, bedside, patient's home).
- Conditions
- PAD, Optical Imaging
- Being tested
- PWVi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PWViDevice
| Study group | Role | What they receive |
|---|---|---|
| Experimental | * ABI < 0.6, confirmed PAD
* 50 - 90 years of age
* In-patients or out-patients
* Participants who understand the study and are able to give consent
* Participants who can be followed by the same investigating team for the whole period of their participation in the study Receives: Device: PWVi | |
| Control | * ABI of 0.9 < ABI < 1.2
* 50 - 90 years of age
* Participants who understand the study and are able to give consent
* Participants who can be followed by the same investigating team for the whole period of their participation in the study Receives: Device: PWVi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waveform Imaging using Pulse Wave Velocity
Using new technology to measure tissue viability in surgical participants.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Why it stopped: No funding received.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PADStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Toronto Metropolitan University
- Responsible party
- Sponsor
- Investigators
- Karen Cross, MD, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516383
- Sponsor's protocol ID
- 16-028
- Acronym
- PWVi
- Status last verified
- Apr 2018
- First submitted
- 24 May 2016
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Aboyans V, Criqui MH, Abraham P, Allison MA, Creager MA, Diehm C, Fowkes FG, Hiatt WR, Jonsson B, Lacroix P, Marin B, McDermott MM, Norgren L, Pande RL, Preux PM, Stoffers HE, Treat-Jacobson D; American Heart Association Council on Peripheral Vascular Disease; Council on Epidemiology and Prevention; Council on Clinical Cardiology; Council on Cardiovascular Nursing; Council on Cardiovascular Radiology and Intervention, and Council on Cardiovascular Surgery and Anesthesia. Measurement and interpretation of the ankle-brachial index: a scientific statement from the American Heart Association. Circulation. 2012 Dec 11;126(24):2890-909. doi: 10.1161/CIR.0b013e318276fbcb. Epub 2012 Nov 16. No abstract available.
PubMed 23159553Beckman JA, Jaff MR, Creager MA. The United States preventive services task force recommendation statement on screening for peripheral arterial disease: more harm than benefit? Circulation. 2006 Aug 22;114(8):861-6. doi: 10.1161/CIRCULATIONAHA.105.607846.
PubMed 16923770
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Wave Velocity Imaging in the Assessment of PAD
- ClinicalTrials.gov ID
- NCT03516383
- Acronym / sponsor ID
- PWVi / 16-028
- Conditions
- PAD, Optical Imaging
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No funding received.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Toronto Metropolitan University
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 4 May 2018 (actual)
- 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.
The purpose of this study is to predict the outcome of peripheral revascularization surgery by use of a new technology developed by our team, Pulse Wave Velocity imaging (PWVI), which has the capability to detect pulse transit time (PTT), and pulse wave velocity (PWV). This PWVI will be compared against known gold standards pre and post lower extremity limb revascularization and used to evaluate outcomes. Specifically, is leg PWV different among those with or without PAD, and is leg PWV different among those who undergo revascularization surgery and those who do not? This study represents the first clinical pilot study of the device with the aim to expand study participant numbers in future research and to eventually develop a PAD screening tool. This would be the first of its kind ever described.
Detailed description
Peripheral artery disease (PAD) is the narrowing of arteries in the extremities, resulting in insufficient blood supply to tissue in the extremities. In its mildest form, PAD may be asymptomatic, or may show mild symptoms such as intermittent claudication (IC), a pain one may experience while walking. [Hirsch et al, 2006; Criqui et al, 1992; Beckman, 2002] At its extreme, PAD may lead to critical limb ischaemia (CLI), necrosis, gangrene, amputation, or even death. [Hirsch et al, 2006; Hirsch et al, 2001; Criqui et al, 1992] PAD affects over 20% of all patients aged 70 and above, or aged 50 to 69 with a history of smoking or diabetes. [Hirsch et al, 2001; Beckman et al, 2006] In primary care, the ankle-brachial index (ABI) has been used as a screening tool for PAD. [Aboyans et al., 2012] The ABI consists of the ratio of systolic blood pressures measured at the ankle to that of the brachial artery. An ABI of 0.9 - 1.1 is considered normal, and ABI ≤ 0.9 is considered abnormal. [Aboyans et al., 2012; Hirsch et al., 2001] By way of the ABI, a primary care practitioner may be able to diagnose PAD with a high degree of specificity (up to 99%), but sensitivity can vary greatly (15-79%). [Xu et al, 2010] More recently, the use of the brachial-ankle pulse wave velocity (baPWV) has been used as another diagnostic tool with regards to coronary artery disease (CAD). [Katakami et al., 2014; Chae et al., 2013; Yamashina et al., 2002] Sugawara et al. have shown that the variability in the baPWV is due 58% to aortic pulse wave velocity (PWV), and 23% to leg PWV. [Sugawara et al., 2005] Although aortic stiffness is a larger component of the baPWV, numerous studies have shown that there is a correlation between baPWV and PAD. [Yokoyama et al., 2003; Amoh-Tonto et al., 2009; Xu et al., 2008] Additionally, it has been shown that baPWV can increase after percutaneous transluminal angioplasty in the lower extremities. [Yokoyama et al., 2003] In context with CLI, although methods of diagnosis have improved over the past decades, amputation rates have seen an increase. [Beckman, 2007] Revascularization surgery has been shown to increase ambulatory function and quality of life in those affected by CLI as compared to those who had undergone amputation. [Brosi et al., 2007; Deneuville \& Perrouillet, 2006; Oresanya et al, 2015] This, and the cut-off ABI value <0.95 set by Motobe et al. in 2005 for the accuracy of baPWV measurements, requires further investigation into leg PWV for a better understanding of PAD and CLI and the effects revascularization surgery has. [Wohlfart et al., 2013] The investigators believe that the ability to determine the success of revascularization surgery at the time of surgery would guide vascular surgeons in the intra-operative treatment and monitoring of these patients. The current standard of care is Doppler of the dorsalis pedis or posterior tibial artery post-operatively and at the bedside. This is not always an accurate determinate of the success of a revascularized limb and subsequently patients require either Duplex ultrasound, computed tomography angiography (CTA) or angiography. The results from these more sophisticated investigations provide accurate information about blood flow and its characteristics. Our group has designed a device called Pulse Wave Velocity imaging (PWVI). This device has the capacity to determine pulse wave velocity, pulse transit time and a waveform analysis at the bedside and can be designed as a small handheld tool. This is essentially a culmination of the information obtained from Duplex ultrasound and photoplethysmography but can be acquired within 30 seconds in any environment (eg. Operating room, bedside, patient's home).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Device: PWVi* ABI < 0.6, confirmed PAD * 50 - 90 years of age * In-patients or out-patients * Participants who understand the study and are able to give consent * Participants who can be followed by the same investigating team for the whole period of their participation in the study |
| Control | – | Device: PWVi* ABI of 0.9 < ABI < 1.2 * 50 - 90 years of age * Participants who understand the study and are able to give consent * Participants who can be followed by the same investigating team for the whole period of their participation in the study |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Group 1 (n=10), the control group, will be recruited via referral from our research team and will consist of healthy individuals with a normal ABI of 0.9 < ABI < 1.2. Group 2 (n=10), participants with PAD, ABI < 0.6, either requiring revascularization surgery (group 2B, n=5), or not (group 2A, n=5). These participants will be recruited from the population routinely seen by the Principal Investigators or team members.
Key inclusion criteria (9 listed)
- ABI of 0.9 < ABI < 1.2
- 50 - 90 years of age
- Participants who understand the study and are able to give consent
- Participants who can be followed by the same investigating team for the whole period of their participation in the study Group 2. Experimental (n=10)
- ABI < 0.6, confirmed PAD
Key exclusion criteria (7 listed)
- Diabetics
- Smokers
- Body mass index (BMI) > 35 Group 2. Experimental (n=10)
- Diabetics
- Smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PWVi | Device | Control, Experimental |
Primary outcome
Waveform Imaging using Pulse Wave Velocity
Time frame: 8 weeks
Using new technology to measure tissue viability in surgical participants.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Background: PubMed 23159553Aboyans V, Criqui MH, Abraham P, Allison MA, Creager MA, Diehm C, Fowkes FG, Hiatt WR, Jonsson B, Lacroix P, Marin B, McDermott MM, Norgren L, Pande RL, Preux PM, Stoffers HE, Treat-Jacobson D; American Heart Association Council on Peripheral Vascular Disease; Council on Epidemiology and Prevention; Council on Clinical Cardiology; Council on Cardiovascular Nursing; Council on Cardiovascular Radiology and Intervention, and Council on Cardiovascular Surgery and Anesthesia. Measurement and interpretation of the ankle-brachial index: a scientific statement from the American Heart Association. Circulation. 2012 Dec 11;126(24):2890-909. doi: 10.1161/CIR.0b013e318276fbcb. Epub 2012 Nov 16. No abstract available.
- Background: PubMed 16923770Beckman JA, Jaff MR, Creager MA. The United States preventive services task force recommendation statement on screening for peripheral arterial disease: more harm than benefit? Circulation. 2006 Aug 22;114(8):861-6. doi: 10.1161/CIRCULATIONAHA.105.607846.
- Individual participant dataSharing planned: No
Related trials for PAD
Active, not recruiting
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Recruiting
The THOR IDE Study
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Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
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Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
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.
Karen Cross, MD, PhD principal investigator
Unity Health Toronto
Questions about this trial
What is this clinical trial studying?
An observational study of PAD and Optical Imaging, run by Unity Health Toronto.
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 9 inclusion and 7 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: withdrawn, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Waveform Imaging using Pulse Wave Velocity (time frame: 8 weeks). 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 NCT03516383, which also lists 2 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 4 May 2018.