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

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Device: AngioDefender

• Registration Number: NCT02641197
• Lead Sponsor: Everist Genomics, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-16
• Study First Submitted QC: 2015-12-22
• Study First Posted: 2015-12-29
• Study Start: 2016-04-06
• Primary Completion: 2016-05-19
• Study Completion: 2016-05-19
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-31
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AngioDefender	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Hotel-Dieu Grace Healthcare; 🇨🇦 Windsor, Ontario, Canada

University of Western Ontario; 🇨🇦 London, Ontario, Canada