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Completed

NCT Number: NCT02641197

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

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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

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Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

AngioDefender

Device

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.

Primary outcomes

  1. Change from baseline %flow-mediation dilation (%FMD) at 1 hour

    Time frame: 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 outcomes

  1. Reproducibility of multiple %FMD determinations by AngioDefender

    Time frame: 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

  2. Incidence of emergent adverse device effects (ADEs) according to CTCAE v4.03

    Time frame: 4 consecutive days (maximum 5 days)

    Spontaneous ADEs reported by the subject and inquiry into emergence of expected/unexpected ADEs

Sponsors and collaborators

Lead sponsor

Everist Genomics, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 29, 2015
Registry last updated
Feb 5, 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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