Brachial Artery Ultrasound Imaging: A Repeatability Study

February 6, 2017 updated by: Everist Genomics, Inc
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Derby, Connecticut, United States, 06418
        • Yale University Prevention Research Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Brachial artery ultrasound imaging

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Everist Genomics, Inc

Investigators

  • Study Chair: Peter F Lenehan, MD PhD, Everist Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

February 9, 2016

First Submitted That Met QC Criteria

February 10, 2016

First Posted (Estimate)

February 15, 2016

Study Record Updates

Last Update Posted (Estimate)

February 8, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-1601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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