Brachial Artery Ultrasound Imaging: A Repeatability Study

E

Everist Genomics

Status

Completed

Conditions

Cardiovascular Diseases

Treatments

Procedure: Brachial artery ultrasound imaging

Study type

Interventional

Funder types

Industry

Identifiers

NCT02682576
A-1601

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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 (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.
  4. Clinical signs and/or symptoms of active viral or bacterial infections
  5. Resting 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

21 participants in 1 patient group

Brachial artery ultrasound imaging
Experimental group
Description:
Brachial artery ultrasound imaging is a non-invasive procedure for detecting endothelial dysfunction by measuring the flow-mediated dilation of the brachial artery using high resolution continuous electrocardiogram-gated B-mode (2D) ultrasound imaging during reactive hyperemia.
Treatment:
Procedure: Brachial artery ultrasound imaging

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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