Brachial Artery Ultrasound Imaging: A Repeatability Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02682576

Enrollment

Registered

2016-02-15

Start date

2016-04-30

Completion date

2016-05-31

Last updated

2017-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

brachial artery ultrasound imaging, flow-mediated dilation, endothelium

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.

Interventions

PROCEDUREBrachial artery ultrasound imaging

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline % flow-mediated dilation (%FMD) at 1 hour	1 hour	Repeat brachial artery ultrasound imaging of the same subject after 1 hour using the same operator and vascular ultrasound equipment

Secondary

Measure	Time frame	Description
Incidence of emergent adverse device effects (ADEs) according to CTCAE v4.03	1 day	Spontaneous ADEs reported by the subject and inquiry into emergence of expected/unexpected ADEs

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026