Brachial Artery Ultrasound Imaging: A Repeatability Study

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Procedure: Brachial artery ultrasound imaging

• Registration Number: NCT02682576
• Lead Sponsor: Everist Genomics, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-02-10
• Study First Posted: 2016-02-15
• Study Start: 2016-04
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brachial artery ultrasound imaging	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Yale University Prevention Research Center; 🇺🇸 Derby, Connecticut, United States