Cardiovascular Diseases
Conditions
Keywords
Physiology
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.
Interventions
DEVICEAngioDefender
DEVICEUltrasound
Sponsors
Everist Genomics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Statistical equivalence of %FMD determined by AngioDefender vs brachial artery ultrasound imaging (BAUI) | 1 day | Deming regression analysis and Bland-Altman Plots |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of types and incidences of emergent adverse device effects | 1 day |
Countries
Canada, United States
Outcome results
None listed