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PADPWViNCT03516383

Pulse Wave Velocity Imaging in the Assessment of PAD

An observational study of PAD and Optical Imaging, run by Unity Health Toronto.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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 groups in NCT03516383
Study groupRoleWhat 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.

  1. 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.

  1. First posted4 May 2018
  2. Study startJun 2016
  3. Primary completionJun 2017 (estimated)
  4. Study completionJun 2017 (estimated)

Why it stopped: No funding received.

Resources

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)
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 23159553
  • Beckman 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

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.

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