Brachial Artery Ultrasound Imaging: A Repeatability Study

Study Overview
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Brief Summary
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The objective of the study is to define the analytical repeatability of quantifying flow-mediated dilation of the brachial artery using brachial artery ultrasound imaging using upper arm cuff occlusion.

Official Title
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Brachial Artery Ultrasound Imaging: A Repeatability Study

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Procedure: Brachial artery ultrasound imaging


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 (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 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: Brachial artery ultrasound imaging<br>Brachial artery ultrasound imaging is a non-invasive procedure for detecting endothelial dysfunction by measuring the flow-mediated dilation of the brachial artery using high resolution continuous electrocardiogram-gated B-mode (2D) ultrasound imaging during reactive hyperemia. | Procedure: Brachial artery ultrasound imaging<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline % flow-mediated dilation (%FMD) at 1 hour | Repeat brachial artery ultrasound imaging of the same subject after 1 hour using the same operator and vascular ultrasound equipment | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brachial artery ultrasound imaging, flow-mediated dilation, endothelium