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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Device: AngioDefender

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • University of Western Ontario
    • Windsor, Ontario, Canada, N9C 3Z4
      • Hotel-Dieu Grace Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Men and women, ≥18 years old
2. 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)
3. Written informed consent understood and signed; understanding of study procedures and ability to comply with them for the length of the study

Exclusion Criteria:

1. Body mass index (BMI) >50 kg/m2
2. Mid-upper arm circumference of arm selected for FMD testing <17 cm or >42 cm
3. 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.
4. Clinical signs and/or symptoms of active viral or bacterial infections
5. Resting muscle tremor or inability to remain still for the duration of the testing period
6. Systolic blood pressure (SBP) at rest of >170 mmHg or diastolic blood pressure (DBP) at rest of ≥110 mmHg.
7. Diabetic subjects - Type I or II
8. Previous intolerable adverse reaction(s) to vascular testing using an upper extremity occlusive pneumatic cuff

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Everist Genomics, Inc
• Investigators: Study Director: Peter F Lenehan, MD PhD, Everist Genomics, Inc

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 6, 2016
• Primary Completion (ACTUAL): May 19, 2016
• Study Completion (ACTUAL): May 19, 2016

Study Registration Dates

• First Submitted: December 16, 2015
• First Submitted That Met QC Criteria: December 22, 2015
• First Posted (ESTIMATE): December 29, 2015

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2018
• Last Update Submitted That Met QC Criteria: January 31, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: cardiovascular diseases; flow-mediated dilation; reproducibility; repeatability; AngioDefender; device precision
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: A-1501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO