Cardiovascular Diseases
Conditions
Keywords
flow-mediated dilation, AngioDefender, device precision, repeatability, reproducibility, cardiovascular diseases
Brief summary
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.
Interventions
DEVICEAngioDefender
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.
Sponsors
Everist Genomics, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Men and women, ≥18 years old 2. 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) 3. Written informed consent understood and signed; understanding of study procedures and ability to comply with them for the length of the study
Exclusion criteria
1. Body mass index (BMI) \>50 kg/m2 2. Mid-upper arm circumference of arm selected for FMD testing \<17 cm or \>42 cm 3. 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. 4. Clinical signs and/or symptoms of active viral or bacterial infections 5. Resting muscle tremor or inability to remain still for the duration of the testing period 6. Systolic blood pressure (SBP) at rest of \>170 mmHg or diastolic blood pressure (DBP) at rest of ≥110 mmHg. 7. Diabetic subjects - Type I or II 8. Previous intolerable adverse reaction(s) to vascular testing using an upper extremity occlusive pneumatic cuff
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline %flow-mediation dilation (%FMD) at 1 hour | Daily x 4 consecutive days | Repeat AD testing of the same subject 1 hour apart on 4 consecutive days (operators and/or AD devices change each day) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reproducibility of multiple %FMD determinations by AngioDefender | Daily x 4 consecutive days | Repeat AD testing of the same subject over 4 consecutive days using different operators and/or AD devices each day |
| Incidence of emergent adverse device effects (ADEs) according to CTCAE v4.03 | 4 consecutive days (maximum 5 days) | Spontaneous ADEs reported by the subject and inquiry into emergence of expected/unexpected ADEs |
Countries
Canada
Outcome results
None listed