Brachial Artery Ultrasound Imaging: A Repeatability Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Brachial artery ultrasound imaging

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.

Group Type EXPERIMENTAL

Brachial artery ultrasound imaging

Intervention Type PROCEDURE

Interventions

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Brachial artery ultrasound imaging

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes