Brachial Artery Ultrasound Imaging: A Repeatability Study



Status:Recruiting
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2016
End Date:May 2016
Contact:Peter F Lenehan, MD PhD
Email:plenehan@everisthealth.com
Phone:734-929-9484

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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.


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
We found this trial at
2
sites
Derby, Connecticut 06418
Principal Investigator: David L Katz, MD MPH
Phone: 203-732-1265
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Michael Widlansky, MD
Phone: 414-955-3148
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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