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

Everist Genomics, Inc20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cardiovascular Diseases

Interventions

AngioDefenderDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

University of Western Ontario

London, Ontario, Canada

Hotel-Dieu Grace Healthcare

Windsor, Ontario, Canada

Outcomes

Primary Outcomes

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)

Time frame: Daily x 4 consecutive days

Secondary Outcomes

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

Time frame: 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

Time frame: 4 consecutive days (maximum 5 days)

Data from ClinicalTrials.gov

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