Vascular Reactivity Assessment by the AngioDefender Device -- A Precision Study

Sponsor

Everist Genomics, Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT02641197

Collaborator

(none)

Enrollment

Locations

Arm

1.4

Actual Duration (Months)

Patients Per Site

7.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to define the repeatability and reproducibility of quantifying flow-mediated dilation (FMD) of the brachial artery (BA) using the AngioDefender (AD) methodology.

Repeatability will be assessed by repeat AD testing of the same subject 1 hour apart, using the same AD device and operator.

Reproducibility will be assessed by comparing FMD scores obtained for the same subject, but using different AD devices and operators.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Vascular Reactivity Assessment by AngioDefender -- A Repeatability and Reproducibility Study

Actual Study Start Date :

Apr 6, 2016

Actual Primary Completion Date :

May 19, 2016

Actual Study Completion Date :

May 19, 2016

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 brachial artery occlusion by a standard upper arm pneumatic blood pressure cuff. The procedure is non-invasive and does not employ ultrasound.	Device: AngioDefender Repeatability will be assessed by repeat AngioDefender (AD) testing of the same subject 1 hour apart, using the same AD device and operator. Reproducibility will be assessed by comparing FMD scores obtained for the same subject, but using different AD devices and operators.

Arm

Intervention/Treatment

Experimental: AngioDefender

The AngioDefender device uses a novel, proprietary software algorithm to analyze pulse wave amplitude data collected before and after brachial artery occlusion by a standard upper arm pneumatic blood pressure cuff. The procedure is non-invasive and does not employ ultrasound.

Device: AngioDefender

Repeatability will be assessed by repeat AngioDefender (AD) testing of the same subject 1 hour apart, using the same AD device and operator. Reproducibility will be assessed by comparing FMD scores obtained for the same subject, but using different AD devices and operators.

Outcome Measures

Primary Outcome Measures

Change from baseline %flow-mediation dilation (%FMD) at 1 hour [Daily x 4 consecutive days]
Repeat AD testing of the same subject 1 hour apart on 4 consecutive days (operators and/or AD devices change each day)

Secondary Outcome Measures

Reproducibility of multiple %FMD determinations by AngioDefender [Daily x 4 consecutive days]
Repeat AD testing of the same subject over 4 consecutive days using different operators and/or AD devices each day
Incidence of emergent adverse device effects (ADEs) according to CTCAE v4.03 [4 consecutive days (maximum 5 days)]
Spontaneous ADEs reported by the subject and inquiry into emergence of expected/unexpected ADEs

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Men and women, ≥18 years old
Eastern Cooperative Oncology Group/Zubrod score performance status of 0, 1, or 2, determined within 7 days prior to FMD testing on Study Day 1 (Visit 1)
Written informed consent understood and signed; understanding of study procedures and ability to comply with them for the length of the study

Exclusion Criteria:

Body mass index (BMI) >50 kg/m2
Mid-upper arm circumference of arm selected for FMD testing <17 cm or >42 cm
Sinus arrhythmia, 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 muscle tremor or inability to remain still for the duration of the testing period
Systolic blood pressure (SBP) at rest of >170 mmHg or diastolic blood pressure (DBP) at rest of ≥110 mmHg.
Diabetic subjects - Type I or II
Previous intolerable adverse reaction(s) to vascular testing using an upper extremity occlusive pneumatic cuff