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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02641197
• Other study ID #: A-1501
• Status: Completed
• Phase: N/A
• First received: December 16, 2015
• Last updated: January 31, 2018
• Start date: April 6, 2016
• Est. completion date: May 19, 2016

Study information

• Verified date: January 2018
• Source: Everist Genomics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 19, 2016
• Est. primary completion date: May 19, 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, 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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Device:
• AngioDefender
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.

Locations

Country	Name	City	State
Canada	University of Western Ontario	London	Ontario
Canada	Hotel-Dieu Grace Healthcare	Windsor	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Everist Genomics, Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reproducibility of multiple %FMD determinations by AngioDefender	Repeat AD testing of the same subject over 4 consecutive days using different operators and/or AD devices each day	Daily x 4 consecutive days
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	4 consecutive days (maximum 5 days)