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Completed

NCT Number: NCT02682576

Brachial Artery Ultrasound Imaging: A Repeatability Study

The objective of the study is to define the analytical repeatability of quantifying flow-mediated dilation of the brachial artery using brachial artery ultrasound imaging using upper arm cuff occlusion.

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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

Yale University Prevention Research Center, Derby, Connecticut, United States

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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 (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 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

Brachial artery ultrasound imaging

Procedure

Primary outcomes

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

    Time frame: 1 hour

    Repeat brachial artery ultrasound imaging of the same subject after 1 hour using the same operator and vascular ultrasound equipment

Secondary outcomes

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

    Time frame: 1 day

    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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 15, 2016
Registry last updated
Feb 8, 2017

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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