AngioDefender Versus Brachial Artery Ultrasound Imaging

Cardiovascular Diseases Clinical Trial

Official title:

Vascular Reactivity Assessment by a Novel Diagnostic Device, ANGIODEFENDER, Compared to Using Brachial Artery Ultrasound Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02468336
• Other study ID #: A-1302
• Status: Completed
• Phase: N/A
• First received: June 7, 2015
• Last updated: January 31, 2018
• Start date: August 2015
• Est. completion date: February 15, 2017

Study information

• Verified date: January 2018
• Source: Everist Genomics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: February 15, 2017
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Device:
• AngioDefender

• Ultrasound

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Everist Genomics, Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Statistical equivalence of %FMD determined by AngioDefender vs brachial artery ultrasound imaging (BAUI)	Deming regression analysis and Bland-Altman Plots	1 day
Secondary	Comparison of types and incidences of emergent adverse device effects		1 day