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Assessment of Three Instruments for the Non-invasive Measurement of Arterial Stiffness. (ASI-2012)

Primary Purpose

Healthy, Diabetes Type 2, Obesity

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ASI Device
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Healthy focused on measuring Pulse Wave Analysis, Arterial Stiffness

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Participants of the Healthy Group must meet the following criteria to be eligible for participation in the study:

  1. Healthy male or female, greater or equal to 20 and less than or equal to 70 years of age;
  2. Willing to comply with the protocol requirements;
  3. Willing to provide informed consent.

Participants of the Obese/Type 2 Diabetes Group must meet the following criteria to be eligible for participation in the study:

  1. Male or female, greater or equal to 20 and less than or equal to 70 years of age;
  2. Presence of clinically diagnosed Type 2 Diabetes, and/or a body mass index (BMI) > 30;
  3. Willing to comply with the protocol requirements;
  4. Willing to provide informed consent.

Participants of the Vascular Disease Group must meet the following criteria to be eligible for participation in the study:

  1. Male or female, greater or equal to 20 and less than or equal to 70 years of age;
  2. Documented evidence of atherosclerosis as manifested by one of the following:

    1. documented myocardial infarction;
    2. documented CAD as defined as >70% stenosis of an epicardial coronary artery;
    3. documented PAD including those with claudication as defined by an ankle brachial index of <0.9;
    4. angiographically documented carotid or lower limb stenosis of >50%
  3. Willing to comply with the protocol requirements;
  4. Willing to provide informed consent -

Exclusion Criteria:

Participants of the Healthy Group will be excluded if they have any of the following:

  1. Presence of a clinically diagnosed disease affecting the circulatory, respiratory, immune, skeletal, urinary, muscular, endocrine, digestive, nervous or reproductive system that requires medical treatment;
  2. Cigarette/cigar smoking, current or within the last 6 months;
  3. Current (within the last 30 days) bacterial, viral or fungal infection;
  4. Taking any prescribed medication (with the exception of birth control or HRT) within the last 3 months or over-the-counter medication within the past 72 h;
  5. Pregnancy;
  6. Amputation or malformation of any limb or extremity (fingers, leg, or arm) which would impede the placement of sensors, probes, or blood pressure cuffs.

Participants of the Obese/Type 2 Diabetes Group will be excluded if they have any of the following:

  1. Documented evidence of atherosclerosis as manifested by one of the following:

    1. documented myocardial infarction;
    2. documented CAD as defined as >70% stenosis of an epicardial coronary artery;
    3. documented PAD including those with claudication as defined by an ankle brachial index of <0.9;
    4. angiographically documented carotid or lower limb stenosis of >50%
    5. having had a documented previous intervention for CAD or PAD.
  2. Cigarette/cigar smoking, current or within the last 6 months;
  3. Current (within the last 30 days) bacterial, viral or fungal infection;
  4. Taking over-the-counter medication within the past 72 h;
  5. Pregnancy;
  6. Amputation or malformation of any limb or extremity (fingers, leg, or arm) which would impede the placement of sensors, probes, or blood pressure cuffs.

Participants of the Vascular Disease Group will be excluded if they have any of the following:

  1. Cigarette/cigar smoking, current or within the last 6 months;
  2. Current (within the last 30 days) bacterial, viral or fungal infection;
  3. Taking over-the-counter medication within the past 72 h;
  4. Pregnancy;
  5. Amputation or malformation of any limb or extremity (fingers, leg, or arm) which would impede the placement of sensors, probes, or blood pressure cuffs.
  6. Having had a documented previous intervention for CAD or PAD

Sites / Locations

  • St. Boniface General Hospital - Asper Clinical Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ASI Device

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 2, 2012
Last Updated
February 11, 2014
Sponsor
University of Manitoba
Collaborators
St. Boniface Hospital, Arterial Stiffness Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01722474
Brief Title
Assessment of Three Instruments for the Non-invasive Measurement of Arterial Stiffness.
Acronym
ASI-2012
Official Title
Assessment of Three Instruments for the Non-invasive Measurement of Arterial Stiffness.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Why Stopped
Minor device modifications required, move revised device to clinical site in USA.
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
St. Boniface Hospital, Arterial Stiffness Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Diabetes Type 2, Obesity, Coronary Artery Disease, Peripheral Arterial Disease
Keywords
Pulse Wave Analysis, Arterial Stiffness

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASI Device
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ASI Device
Other Intervention Name(s)
ASI Non-Invasive Arterial Stiffness Screening Device
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants of the Healthy Group must meet the following criteria to be eligible for participation in the study: Healthy male or female, greater or equal to 20 and less than or equal to 70 years of age; Willing to comply with the protocol requirements; Willing to provide informed consent. Participants of the Obese/Type 2 Diabetes Group must meet the following criteria to be eligible for participation in the study: Male or female, greater or equal to 20 and less than or equal to 70 years of age; Presence of clinically diagnosed Type 2 Diabetes, and/or a body mass index (BMI) > 30; Willing to comply with the protocol requirements; Willing to provide informed consent. Participants of the Vascular Disease Group must meet the following criteria to be eligible for participation in the study: Male or female, greater or equal to 20 and less than or equal to 70 years of age; Documented evidence of atherosclerosis as manifested by one of the following: documented myocardial infarction; documented CAD as defined as >70% stenosis of an epicardial coronary artery; documented PAD including those with claudication as defined by an ankle brachial index of <0.9; angiographically documented carotid or lower limb stenosis of >50% Willing to comply with the protocol requirements; Willing to provide informed consent - Exclusion Criteria: Participants of the Healthy Group will be excluded if they have any of the following: Presence of a clinically diagnosed disease affecting the circulatory, respiratory, immune, skeletal, urinary, muscular, endocrine, digestive, nervous or reproductive system that requires medical treatment; Cigarette/cigar smoking, current or within the last 6 months; Current (within the last 30 days) bacterial, viral or fungal infection; Taking any prescribed medication (with the exception of birth control or HRT) within the last 3 months or over-the-counter medication within the past 72 h; Pregnancy; Amputation or malformation of any limb or extremity (fingers, leg, or arm) which would impede the placement of sensors, probes, or blood pressure cuffs. Participants of the Obese/Type 2 Diabetes Group will be excluded if they have any of the following: Documented evidence of atherosclerosis as manifested by one of the following: documented myocardial infarction; documented CAD as defined as >70% stenosis of an epicardial coronary artery; documented PAD including those with claudication as defined by an ankle brachial index of <0.9; angiographically documented carotid or lower limb stenosis of >50% having had a documented previous intervention for CAD or PAD. Cigarette/cigar smoking, current or within the last 6 months; Current (within the last 30 days) bacterial, viral or fungal infection; Taking over-the-counter medication within the past 72 h; Pregnancy; Amputation or malformation of any limb or extremity (fingers, leg, or arm) which would impede the placement of sensors, probes, or blood pressure cuffs. Participants of the Vascular Disease Group will be excluded if they have any of the following: Cigarette/cigar smoking, current or within the last 6 months; Current (within the last 30 days) bacterial, viral or fungal infection; Taking over-the-counter medication within the past 72 h; Pregnancy; Amputation or malformation of any limb or extremity (fingers, leg, or arm) which would impede the placement of sensors, probes, or blood pressure cuffs. Having had a documented previous intervention for CAD or PAD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter C Zahradka, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Boniface General Hospital - Asper Clinical Research Institute
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
12022246
Citation
O'Rourke MF, Staessen JA, Vlachopoulos C, Duprez D, Plante GE. Clinical applications of arterial stiffness; definitions and reference values. Am J Hypertens. 2002 May;15(5):426-44. doi: 10.1016/s0895-7061(01)02319-6.
Results Reference
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PubMed Identifier
17000623
Citation
Laurent S, Cockcroft J, Van Bortel L, Boutouyrie P, Giannattasio C, Hayoz D, Pannier B, Vlachopoulos C, Wilkinson I, Struijker-Boudier H; European Network for Non-invasive Investigation of Large Arteries. Expert consensus document on arterial stiffness: methodological issues and clinical applications. Eur Heart J. 2006 Nov;27(21):2588-605. doi: 10.1093/eurheartj/ehl254. Epub 2006 Sep 25.
Results Reference
background
PubMed Identifier
17227586
Citation
Weatherley BD, Nelson JJ, Heiss G, Chambless LE, Sharrett AR, Nieto FJ, Folsom AR, Rosamond WD. The association of the ankle-brachial index with incident coronary heart disease: the Atherosclerosis Risk In Communities (ARIC) study, 1987-2001. BMC Cardiovasc Disord. 2007 Jan 16;7:3. doi: 10.1186/1471-2261-7-3.
Results Reference
result
PubMed Identifier
21976274
Citation
Ding FH, Fan WX, Zhang RY, Zhang Q, Li Y, Wang JG. Validation of the noninvasive assessment of central blood pressure by the SphygmoCor and Omron devices against the invasive catheter measurement. Am J Hypertens. 2011 Dec;24(12):1306-11. doi: 10.1038/ajh.2011.145. Epub 2011 Oct 6.
Results Reference
result
PubMed Identifier
9886900
Citation
Wilkinson IB, Fuchs SA, Jansen IM, Spratt JC, Murray GD, Cockcroft JR, Webb DJ. Reproducibility of pulse wave velocity and augmentation index measured by pulse wave analysis. J Hypertens. 1998 Dec;16(12 Pt 2):2079-84. doi: 10.1097/00004872-199816121-00033.
Results Reference
result
PubMed Identifier
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Citation
Siebenhofer A, Kemp C, Sutton A, Williams B. The reproducibility of central aortic blood pressure measurements in healthy subjects using applanation tonometry and sphygmocardiography. J Hum Hypertens. 1999 Sep;13(9):625-9. doi: 10.1038/sj.jhh.1000887.
Results Reference
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PubMed Identifier
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Citation
Dhindsa M, Sommerlad SM, DeVan AE, Barnes JN, Sugawara J, Ley O, Tanaka H. Interrelationships among noninvasive measures of postischemic macro- and microvascular reactivity. J Appl Physiol (1985). 2008 Aug;105(2):427-32. doi: 10.1152/japplphysiol.90431.2008. Epub 2008 May 15.
Results Reference
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Assessment of Three Instruments for the Non-invasive Measurement of Arterial Stiffness.

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