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AngioDefender Versus Brachial Artery Ultrasound Imaging

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ClinicalTrials.gov Identifier: NCT02468336
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Everist Genomics, Inc

Brief Summary:
The objective of this study is to demonstrate that the investigational device, AngioDefender, is comparable to the established procedure referred to as 'brachial artery ultrasound imaging' in their abilities to quantify flow-mediated vasodilation of the brachial artery.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Device: AngioDefender Device: Ultrasound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Vascular Reactivity Assessment by a Novel Diagnostic Device, ANGIODEFENDER, Compared to Using Brachial Artery Ultrasound Imaging
Actual Study Start Date : August 2015
Actual Primary Completion Date : February 15, 2017
Actual Study Completion Date : February 15, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AngioDefender
The AngioDefender device uses a novel, proprietary software algorithm to analyze pulse wave amplitude data collected before and after BA occlusion by a standard upper arm sphygmomanometric blood pressure (BP) cuff. The procedure is non-invasive and employs neither ultrasound nor Doppler flow analysis.
Device: AngioDefender
Active Comparator: Brachial Artery Ultrasound Imaging
A non-invasive procedure for detecting endothelial dysfunction by measuring the flow-mediated dilation of the brachial artery (BA) using high resolution continuous ECG-gated B-mode (2D) ultrasound imaging during reactive hyperemia, a state of transient increase in tissue blood flow that occurs following a brief period of ischemia, e.g., BA occlusion. BA diameter is measured at end-diastole, coincident with the R wave of a simultaneously recorded ECG.
Device: Ultrasound



Primary Outcome Measures :
  1. Statistical equivalence of %FMD determined by AngioDefender vs brachial artery ultrasound imaging (BAUI) [ Time Frame: 1 day ]
    Deming regression analysis and Bland-Altman Plots


Secondary Outcome Measures :
  1. Comparison of types and incidences of emergent adverse device effects [ Time Frame: 1 day ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ECOG 0-2

Exclusion Criteria:

  1. Body mass index (BMI) >50 kg/m2
  2. Mid-upper arm circumference of arm selected for FMD testing <17 cm or >40 cm
  3. Sinus arrhythmia (RR intervals vary by >50%), atrial fibrillation, atrial flutter, multifocal atrial tachycardia, frequent (>1 per 10-sec strip) premature atrial or ventricular contractions (isolated, non-isolated, or alternating), documented by 12-lead ECG with rhythm strip at the time of subject screening.
  4. Clinical signs and/or symptoms of active viral or bacterial infections
  5. Resting tremor or inability to remain still for the duration of AD and BAUI testing
  6. Systolic blood pressure (SBP) at rest of >170 mmHg or diastolic blood pressure (DBP) at rest of ≥110 mmHg.
  7. Previous intolerable adverse reaction(s) to vascular testing using an upper extremity occlusive pneumatic cuff

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468336


Locations
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United States, Colorado
University of Colorado, Boulder
Boulder, Colorado, United States, 80303
United States, Connecticut
Yale University Prevention Research Center
Derby, Connecticut, United States, 06418
United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02118
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, Ontario
University of Western Ontario
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Everist Genomics, Inc
Investigators
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Study Director: Peter F Lenehan, MD PhD Everist Health
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Responsible Party: Everist Genomics, Inc
ClinicalTrials.gov Identifier: NCT02468336    
Other Study ID Numbers: A-1302
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Everist Genomics, Inc:
Physiology
Additional relevant MeSH terms:
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Cardiovascular Diseases