AngioDefender Versus Brachial Artery Ultrasound Imaging

Study Overview
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Brief Summary
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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.

Official Title
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Vascular Reactivity Assessment by a Novel Diagnostic Device, ANGIODEFENDER, Compared to Using Brachial Artery Ultrasound Imaging

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Device: AngioDefender
* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ECOG 0-2 Exclusion Criteria: Body mass index (BMI) >50 kg/m2 Mid-upper arm circumference of arm selected for FMD testing <17 cm or >40 cm 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. Clinical signs and/or symptoms of active viral or bacterial infections Resting tremor or inability to remain still for the duration of AD and BAUI testing Systolic blood pressure (SBP) at rest of >170 mmHg or diastolic blood pressure (DBP) at rest of ≥110 mmHg. Previous intolerable adverse reaction(s) to vascular testing using an upper extremity occlusive pneumatic cuff

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AngioDefender<br>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<br> <br> |
| Active Comparator: Brachial Artery Ultrasound Imaging<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statistical equivalence of %FMD determined by AngioDefender vs brachial artery ultrasound imaging (BAUI) | Deming regression analysis and Bland-Altman Plots | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of types and incidences of emergent adverse device effects |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physiology