Brachial Artery Ultrasound Imaging: A Repeatability Study

Completed · Not applicable

Conditions studied: Cardiovascular Diseases

In brief

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.

Key facts

Study ID

NCT02682576

Run by

Everist Genomics, Inc

People needed

21

Starts

2016-04-01

Expected to finish

2016-05-01

Last updated by the study team

2017-02-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Yale University Prevention Research Center — Derby, Connecticut, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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