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OpenTrials
Completed

NCT Number: NCT02468336

AngioDefender Versus Brachial Artery Ultrasound Imaging

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.

Completed

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Key information

Conditions

Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Western Ontario, London, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AngioDefender

Device

Ultrasound

Device

Primary outcomes

  1. Statistical equivalence of %FMD determined by AngioDefender vs brachial artery ultrasound imaging (BAUI)

    Time frame: 1 day

    Deming regression analysis and Bland-Altman Plots

Secondary outcomes

  1. Comparison of types and incidences of emergent adverse device effects

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Everist Genomics, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 10, 2015
Registry last updated
Feb 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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