Vascular Reactivity Assessment by the AngioDefender Device -- A Precision Study

Study Overview
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Brief Summary
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The objective of this study is to define the repeatability and reproducibility of quantifying flow-mediated dilation (FMD) of the brachial artery (BA) using the AngioDefender (AD) methodology. Repeatability will be assessed by repeat AD testing of the same subject 1 hour apart, using the same AD device and operator. Reproducibility will be assessed by comparing FMD scores obtained for the same subject, but using different AD devices and operators.

Official Title
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Vascular Reactivity Assessment by AngioDefender -- A Repeatability and Reproducibility Study

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Device: AngioDefender


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, ≥18 years old Eastern Cooperative Oncology Group/Zubrod score performance status of 0, 1, or 2, determined within 7 days prior to FMD testing on Study Day 1 (Visit 1) Written informed consent understood and signed; understanding of study procedures and ability to comply with them for the length of the study Exclusion Criteria: Body mass index (BMI) >50 kg/m2 Mid-upper arm circumference of arm selected for FMD testing <17 cm or >42 cm Sinus arrhythmia, 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 muscle tremor or inability to remain still for the duration of the testing period Systolic blood pressure (SBP) at rest of >170 mmHg or diastolic blood pressure (DBP) at rest of ≥110 mmHg. Diabetic subjects - Type I or II 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


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 brachial artery occlusion by a standard upper arm pneumatic blood pressure cuff. The procedure is non-invasive and does not employ ultrasound. | Device: AngioDefender<br>* Repeatability will be assessed by repeat AngioDefender (AD) testing of the same subject 1 hour apart, using the same AD device and operator. Reproducibility will be assessed by comparing FMD scores obtained for the same subject, but using different AD devices and operators.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline %flow-mediation dilation (%FMD) at 1 hour | Repeat AD testing of the same subject 1 hour apart on 4 consecutive days (operators and/or AD devices change each day) | Daily x 4 consecutive days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reproducibility of multiple %FMD determinations by AngioDefender | Repeat AD testing of the same subject over 4 consecutive days using different operators and/or AD devices each day | Daily x 4 consecutive days | 
| Incidence of emergent adverse device effects (ADEs) according to CTCAE v4.03 | Spontaneous ADEs reported by the subject and inquiry into emergence of expected/unexpected ADEs | 4 consecutive days (maximum 5 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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flow-mediated dilation, AngioDefender, device precision, repeatability, reproducibility, cardiovascular diseases