Pulse Wave Velocity Imaging in the Assessment of PAD

NCT03516383 | Withdrawn

• 1 other identifier: 16-028
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

PAD; Optical Imaging

Outcome Measures

Primary Outcomes (1)

• Waveform Imaging using Pulse Wave Velocity

  Using new technology to measure tissue viability in surgical participants.

  8 weeks

Study Arms (2)

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

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

Device: PWVi

Interventions

PWVi DEVICE

Control; Experimental

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• ABI of 0.9 \< ABI \< 1.2
• 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
• 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

You may not qualify if:

• Diabetics
• Smokers
• Body mass index (BMI) \> 35 Group 2. Experimental (n=10)
• Diabetics
• Smokers
• Advanced lymphedema or dermatoliposclerosis
• BMI \> 35

Sponsors & Collaborators

• Unity Health Toronto: lead
• Toronto Metropolitan University: collaborator

Related Publications (2)

• 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.

  PMID: 23159553 BACKGROUND

• 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.

  PMID: 16923770 BACKGROUND

Study Officials

• Karen Cross, MD, PhD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: May 4, 2018
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 4, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share