AngioDefender Versus Brachial Artery Ultrasound Imaging

Not Applicable

Completed

• Conditions: Cardiovascular Diseases

• 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

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)

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