AngioDefender Versus Brachial Artery Ultrasound Imaging

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Device: AngioDefender; Device: Ultrasound

• Registration Number: NCT02468336
• Lead Sponsor: Everist Genomics, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-07
• Study First Submitted QC: 2015-06-09
• Study First Posted: 2015-06-10
• Study Start: 2015-08
• Primary Completion: 2017-02-15
• Study Completion: 2017-02-15
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-31
• Last Update Posted: 2018-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AngioDefender	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.
Brachial Artery Ultrasound Imaging	Ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Statistical equivalence of %FMD determined by AngioDefender vs brachial artery ultrasound imaging (BAUI)	1 day	Deming regression analysis and Bland-Altman Plots

Secondary Outcome Measures

Name	Time	Method
Comparison of types and incidences of emergent adverse device effects	1 day

Trial Locations

Locations (5)

Boston University; 🇺🇸 Boston, Massachusetts, United States

University of Colorado, Boulder; 🇺🇸 Boulder, Colorado, United States

University of Western Ontario; 🇨🇦 London, Ontario, Canada

Yale University Prevention Research Center; 🇺🇸 Derby, Connecticut, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States