Loading clinical trials...

Vascular Reactivity Assessment by the AngioDefender Device -- A Precision Study | Clinical Trials | Clareo Health

COMPLETEDNA

Vascular Reactivity Assessment by the AngioDefender Device -- A Precision Study

Vascular Reactivity Assessment by AngioDefender -- A Repeatability and Reproducibility Study

NCT02641197•Everist Genomics, Inc

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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, 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 muscle 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

Locations (2)

University of Western Ontario

London, Ontario, Canada

Hotel-Dieu Grace Healthcare

Windsor, Ontario, Canada

Key Dates

Start Date

April 6, 2016

Primary Completion Date

May 19, 2016

Completion Date

May 19, 2016

Last Updated

February 5, 2018

Enrollment

ACTUAL participants

Conditions

Cardiovascular Diseases

Interventions

AngioDefender

DEVICE

The Prevalence, Disease Burden and Prognosis of COPD in Patients With Cardiovascular Diseases

NCT06909773

Cardiovascular Diseases

View study

RECRUITINGNA

OPTImizing CArdiac REhabilitation by REfining Sleep and STress

NCT06505109

Cardiovascular DiseasesCardiac Rehabilitation

View study

RECRUITINGNA

CLEANer Aspiration for Pulmonary Embolism

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Vascular Reactivity Assessment by the AngioDefender Device -- A Precision Study

Inclusion Criteria

Exclusion Criteria

The Prevalence, Disease Burden and Prognosis of COPD in Patients With Cardiovascular Diseases

OPTImizing CArdiac REhabilitation by REfining Sleep and STress

CLEANer Aspiration for Pulmonary Embolism

The CACHE Study: Coronary Artery Care in HaEmophilia

Effects of Exergaming to Reduce Sedentary Time in Inactive Patients With Heart Failure

A Pilot Feasibility and Acceptability Study of Remote ExerciSe Training mOdalities (PRESTO)