Vascular Reactivity Assessment by a Novel Diagnostic Device, ANGIODEFENDER, Compared to Using Brachial Artery Ultrasound Imaging
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Everist Genomics, Inc
- Enrollment
- 171
- Locations
- 5
- Primary Endpoint
- Statistical equivalence of %FMD determined by AngioDefender vs brachial artery ultrasound imaging (BAUI)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
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
Arms & Interventions
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.
Intervention: AngioDefender (Device)
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.
Intervention: Ultrasound (Device)
Outcomes
Primary Outcomes
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 Outcomes
- Comparison of types and incidences of emergent adverse device effects(1 day)