AngioDefender Versus Brachial Artery Ultrasound Imaging

Completed · Not applicable

Conditions studied: Cardiovascular Diseases

In brief

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.

Key facts

Study ID: NCT02468336
Run by: Everist Genomics, Inc
People needed: 171
Starts: 2015-08-01
Expected to finish: 2017-02-15
Last updated by the study team: 2018-02-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

ECOG 0-2

You may not qualify if…

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

Where it is running

University of Colorado, Boulder — Boulder, Colorado, United States
Yale University Prevention Research Center — Derby, Connecticut, United States
Boston University — Boston, Massachusetts, United States
Medical College of Wisconsin — Milwaukee, Wisconsin, United States
University of Western Ontario — London, Ontario, Canada

Full record on ClinicalTrials.gov

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