NCT02641197

Brief Summary

The objective of this study is to define the repeatability and reproducibility of quantifying flow-mediated dilation (FMD) of the brachial artery (BA) using the AngioDefender (AD) methodology. Repeatability will be assessed by repeat AD testing of the same subject 1 hour apart, using the same AD device and operator. Reproducibility will be assessed by comparing FMD scores obtained for the same subject, but using different AD devices and operators.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

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

December 16, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 29, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

April 6, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2016

Completed
Last Updated

February 5, 2018

Status Verified

January 1, 2018

Enrollment Period

1 month

First QC Date

December 16, 2015

Last Update Submit

January 31, 2018

Conditions

Cardiovascular Diseases

Keywords

flow-mediated dilationAngioDefenderdevice precisionrepeatabilityreproducibilitycardiovascular diseases

Outcome Measures

Primary Outcomes (1)

  • Change from baseline %flow-mediation dilation (%FMD) at 1 hour

    Repeat AD testing of the same subject 1 hour apart on 4 consecutive days (operators and/or AD devices change each day)

    Daily x 4 consecutive days

Secondary Outcomes (2)

  • Reproducibility of multiple %FMD determinations by AngioDefender

    Daily x 4 consecutive days

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

    4 consecutive days (maximum 5 days)

Study Arms (1)

AngioDefender

EXPERIMENTAL

The AngioDefender device uses a novel, proprietary software algorithm to analyze pulse wave amplitude data collected before and after brachial artery occlusion by a standard upper arm pneumatic blood pressure cuff. The procedure is non-invasive and does not employ ultrasound.

Device: AngioDefender

Interventions

AngioDefenderDEVICE

Repeatability will be assessed by repeat AngioDefender (AD) testing of the same subject 1 hour apart, using the same AD device and operator. Reproducibility will be assessed by comparing FMD scores obtained for the same subject, but using different AD devices and operators.

AngioDefender

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, 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 muscle 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)

University of Western Ontario

London, Ontario, N6A 5A5, Canada

Location

Hotel-Dieu Grace Healthcare

Windsor, Ontario, N9C 3Z4, Canada

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Peter F Lenehan, MD PhD

    Everist Genomics, Inc

    STUDY DIRECTOR

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

December 16, 2015

First Posted

December 29, 2015

Study Start

April 6, 2016

Primary Completion

May 19, 2016

Study Completion

May 19, 2016

Last Updated

February 5, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)