NCT02682576

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

1 month

First QC Date

February 9, 2016

Last Update Submit

February 6, 2017

Conditions

Cardiovascular Diseases

Keywords

brachial artery ultrasound imagingflow-mediated dilationendothelium

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Incidence of emergent adverse device effects (ADEs) according to CTCAE v4.03

    1 day

Study Arms (1)

Brachial artery ultrasound imaging

EXPERIMENTAL

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

Interventions

Brachial artery ultrasound imagingPROCEDURE
Brachial artery ultrasound imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women, ≥18 years old
  • 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)
  • Written informed consent understood and signed; understanding of study procedures and ability to comply with them for the length of the study

You may not qualify if:

  • Body mass index (BMI) \>50 kg/m2
  • Mid-upper arm circumference of arm selected for FMD testing \<17 cm or \>42 cm
  • 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.
  • Clinical signs and/or symptoms of active viral or bacterial infections
  • Resting tremor or inability to remain still for the duration of the testing period
  • Systolic blood pressure (SBP) at rest of \>170 mmHg or diastolic blood pressure (DBP) at rest of ≥110 mmHg.
  • Diabetic subjects - Type I or II
  • Previous intolerable adverse reaction(s) to vascular testing using an upper extremity occlusive pneumatic cuff

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale University Prevention Research Center

Derby, Connecticut, 06418, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Peter F Lenehan, MD PhD

    Everist Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2016

First Posted

February 15, 2016

Study Start

April 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

February 8, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)