Assessment of Three Instruments for the Non-invasive Measurement of Arterial Stiffness. (ASI-2012)
|ClinicalTrials.gov Identifier: NCT01722474|
Recruitment Status : Terminated (Minor device modifications required, move revised device to clinical site in USA.)
First Posted : November 6, 2012
Last Update Posted : February 12, 2014
The ASI Non-Invasive Arterial Stiffness Screening Device (ASI Device) is an investigational device under development for the non-invasive assessment of arterial stiffness. The ASI Device is considerably smaller and more cost effective than its commercially available counterparts. As the device is readily portable, it is intended to be targeted for use in the community (or at home), as opposed to within the hospital or clinic setting only. However, as the device is still under development, it is not known whether it is capable of determining arterial stiffness with the same sensitivity and consistency as those already in commercial use. An added variable is the fact the sensor for the ASI Device is located on the fingertip.
Validation is a prerequisite for obtaining Health Canada approval of devices for diagnostic purposes. The ASI Device has not been tested against other instruments capable of providing similar measurements. Therefore, a clinical trial to compare the ASI Device against similar devices is necessary. The study will compare measurements of arterial stiffness and other central haemodynamic parameters obtained with the ASI Device against similar measurements from devices that have already been approved for this purpose by Health Canada/United States Food and Drug Administration (FDA).
|Condition or disease||Intervention/treatment|
|Healthy Diabetes Type 2 Obesity Coronary Artery Disease Peripheral Arterial Disease||Device: ASI Device|
This is an exploratory, proof of concept, open sequential registration comparative study designed to establish the utility and accuracy of the ASI Non-Invasive Arterial Stiffness Screening Device (ASI-Device) for the non-invasive vascular assessment of arterial stiffness relative to other such devices already approved and commercially available in Canada and the United States.
The pressure exerted from the contraction of the heart creates a wave form, which travels down the individual's arterial trunk to all parts of the body. The velocity (speed) at which this wave form travels can serve as an indicator of the degree of arterial stiffness. The faster the speed of travel of the pulse wave the stiffer the arteries. It has been demonstrated in other studies that the contour (shape) of the waveform can be affected by the pulse wave velocity and that analysis of this shape is an acceptable surrogate for determining the pulse wave velocity and ultimately determining the severity of arterial stiffness. This method of analysing the contour of the pulse wave to determine the severity of arterial stiffness is called pulse wave analysis (PWA).
The ASI Device non-invasively measures the severity of arterial stiffness derived through pulse wave analysis. The study will compare measurements of arterial stiffness and other central haemodynamic parameters, as derived through pulse wave analysis obtained with the ASI Device, against similar measurements from the SphygmoCor Px System from AtCor and the CR-2000 CV Profiler from Hypertension Inc, devices that already have approval for this purpose by Health Canada and/or the United States Food and Drug Administration.
Three groups of individuals will be sought;
- Healthy participants (n=25)
- Persons with Type 2 Diabetes and/or Obesity (n=15)
- Persons with a diagnosed Cardiovascular/Vascular disease (such as CAD or PAD) (n=15)
Participants will be asked to provide written informed consent prior to participation in the study. Eligible participants will be asked to attend an in-person visit where they will undergo the non-invasive vascular testing. Testing will be comprised of:
- Pulse Wave Analysis using the ASI Device
- Pulse Wave Analysis using the SphygmoCor Device
- Pulse Wave Analysis using the CR-2000 CV Profiler
Although pulse wave contour analysis (PWA) has been demonstrated to be an acceptable surrogate for the assessment of arterial stiffness, Pulse Wave Velocity has been the gold standard for the assessment of arterial stiffness. As such, the VP-1000, a non-invasive vascular screening device, will also be used to measure pulse wave velocity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of Three Instruments for the Non-invasive Measurement of Arterial Stiffness.|
|Study Start Date :||October 2012|
|Primary Completion Date :||July 2013|
|Study Completion Date :||September 2013|
Experimental: ASI Device
Study Participants will attend the research clinic one time (one visit) for the vascular testing. Each instrument/assessment will be run sequentially starting with the Arterial Stiffness Screening Device, then followed by SphygmoCor system, which will then be followed by the CR-2000 CV Profiler, then finally the VP-1000.
Device: ASI Device
Other Name: ASI Non-Invasive Arterial Stiffness Screening Device
- To compare the ability of the non-invasive ASI Device to determine arterial stiffness as compared to SphygmoCor, CR-2000 CV Profiler and VP-1000. [ Time Frame: 1 day ]The average, median, and standard deviation of outcomes from PWA (i.e. augmentation index, or equivalent stiffness index), will be calculated and a correlation analysis conducted to compare the results obtained from each instrument.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01722474
|St. Boniface General Hospital - Asper Clinical Research Institute|
|Winnipeg, Manitoba, Canada, R2H 2A6|
|Principal Investigator:||Peter C Zahradka, PhD||University of Manitoba|