Brachial Artery Ultrasound Imaging: A Repeatability Study

Cardiovascular Diseases Clinical Trial

Official title:

Brachial Artery Ultrasound Imaging: A Repeatability Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02682576
• Other study ID #: A-1601
• Status: Completed
• Phase: N/A
• First received: February 9, 2016
• Last updated: February 6, 2017
• Start date: April 2016
• Est. completion date: May 2016

Study information

• Verified date: February 2017
• Source: Everist Genomics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Procedure:
• Brachial artery ultrasound imaging

Locations

Country	Name	City	State
United States	Yale University Prevention Research Center	Derby	Connecticut
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Everist Genomics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline % flow-mediated dilation (%FMD) at 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	Incidence of emergent adverse device effects (ADEs) according to CTCAE v4.03	Spontaneous ADEs reported by the subject and inquiry into emergence of expected/unexpected ADEs	1 day