AngioDefender Versus Brachial Artery Ultrasound Imaging

Sponsor

Everist Genomics, Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT02468336

Collaborator

(none)

171

Enrollment

Locations

Arms

18.5

Actual Duration (Months)

34.2

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases	Device: AngioDefender Device: Ultrasound	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

171 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Feb 15, 2017

Actual Study Completion Date :

Feb 15, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: AngioDefender
Active Comparator: Brachial Artery Ultrasound Imaging 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.	Device: Ultrasound

Arm

Intervention/Treatment

Experimental: 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.

Device: AngioDefender

Active Comparator: Brachial Artery Ultrasound Imaging

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.

Device: Ultrasound

Outcome Measures

Primary Outcome Measures

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

Comparison of types and incidences of emergent adverse device effects [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

ECOG 0-2

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado, Boulder	Boulder	Colorado	United States	80303
2	Yale University Prevention Research Center	Derby	Connecticut	United States	06418
3	Boston University	Boston	Massachusetts	United States	02118
4	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
5	University of Western Ontario	London	Ontario	Canada	N6A 5A5

Sponsors and Collaborators

Everist Genomics, Inc

Investigators

Study Director: Peter F Lenehan, MD PhD, Everist Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Everist Genomics, Inc

ClinicalTrials.gov Identifier:

NCT02468336

Other Study ID Numbers:

A-1302

First Posted:

Jun 10, 2015

Last Update Posted:

Feb 1, 2018

Last Verified:

Jan 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Everist Genomics, Inc

Physiology

Additional relevant MeSH terms:

Cardiovascular Diseases

Study Results

No Results Posted as of Feb 1, 2018