Brachial Artery Ultrasound Imaging: A Repeatability Study

Everist Genomics, Inc2 sites in 1 country21 target enrollmentApril 2016

ConditionsCardiovascular Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cardiovascular Diseases
Sponsor: Everist Genomics, Inc
Enrollment: 21
Locations: 2
Primary Endpoint: Change from baseline % flow-mediated dilation (%FMD) at 1 hour
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 2016

End Date

May 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Everist Genomics, Inc

Responsible Party

Sponsor

Eligibility Criteria

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