Cardiovascular DiseasesNCT02468336
AngioDefender Versus Brachial Artery Ultrasound Imaging
A study testing AngioDefender and Ultrasound in people with Cardiovascular Diseases, run by Everist Genomics, Inc at 5 sites in 2 countries.
Trial summary
The objective of this study is to demonstrate that the investigational device, AngioDefender, is comparable to the established procedure referred to as 'brachial artery ultrasound imaging' in their abilities to quantify flow-mediated vasodilation of the brachial artery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- AngioDefender and Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Aug 2015to 15 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ECOG 0-2
Who cannot join
- Body mass index (BMI) >50 kg/m2
- Mid-upper arm circumference of arm selected for FMD testing <17 cm or >40 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 AD and BAUI testing
- Systolic blood pressure (SBP) at rest of >170 mmHg or diastolic blood pressure (DBP) at rest of ≥110 mmHg.
- Previous intolerable adverse reaction(s) to vascular testing using an upper extremity occlusive pneumatic cuff
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Boston University
Boston, Massachusetts, 02118
University of Colorado, Boulder
Boulder, Colorado, 80303
Yale University Prevention Research Center
Derby, Connecticut, 06418
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Vascular Reactivity Assessment by a Novel Diagnostic Device, ANGIODEFENDER, Compared to Using Brachial Artery Ultrasound Imaging
The objective of this study is to demonstrate that the investigational device, AngioDefender, is comparable to the established procedure referred to as 'brachial artery ultrasound imaging' in their abilities to quantify flow-mediated vasodilation of the brachial artery.
- Conditions
- Cardiovascular Diseases
- Being tested
- AngioDefender, Ultrasound
- Keywords
- Physiology
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngioDefenderDevice
UltrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| AngioDefender | Experimental | The AngioDefender device uses a novel, proprietary software algorithm to analyze pulse wave amplitude data collected before and after BA occlusion by a standard upper arm sphygmomanometric blood pressure (BP) cuff. The procedure is non-invasive and employs neither ultrasound nor Doppler flow analysis. Receives: Device: AngioDefender |
| Brachial Artery Ultrasound Imaging | Active comparator | A non-invasive procedure for detecting endothelial dysfunction by measuring the flow-mediated dilation of the brachial artery (BA) using high resolution continuous ECG-gated B-mode (2D) ultrasound imaging during reactive hyperemia, a state of transient increase in tissue blood flow that occurs following a brief period of ischemia, e.g., BA occlusion. BA diameter is measured at end-diastole, coincident with the R wave of a simultaneously recorded ECG. Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statistical equivalence of %FMD determined by AngioDefender vs brachial artery ultrasound imaging (BAUI)
Deming regression analysis and Bland-Altman Plots
Measured: 1 day
Secondary outcomes (1)
Comparison of types and incidences of emergent adverse device effects
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startAug 2015
- Primary completion15 Feb 2017
- Study completion15 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Everist Genomics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter F Lenehan, MD PhD, Study director, Everist Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468336
- Sponsor's protocol ID
- A-1302
- Status last verified
- Jan 2018
- First submitted
- 7 Jun 2015
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Reactivity Assessment by a Novel Diagnostic Device, ANGIODEFENDER, Compared to Using Brachial Artery Ultrasound Imaging
- ClinicalTrials.gov ID
- NCT02468336
- Acronym / sponsor ID
- A-1302
- Conditions
- Cardiovascular Diseases
- Keywords
- Physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Everist Genomics, IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2015 (actual)
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 15 Feb 2017 (actual)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to demonstrate that the investigational device, AngioDefender, is comparable to the established procedure referred to as 'brachial artery ultrasound imaging' in their abilities to quantify flow-mediated vasodilation of the brachial artery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AngioDefender | Experimental | Device: AngioDefenderThe AngioDefender device uses a novel, proprietary software algorithm to analyze pulse wave amplitude data collected before and after BA occlusion by a standard upper arm sphygmomanometric blood pressure (BP) cuff. The procedure is non-invasive and employs neither ultrasound nor Doppler flow analysis. |
| Brachial Artery Ultrasound Imaging | Active comparator | Device: UltrasoundA non-invasive procedure for detecting endothelial dysfunction by measuring the flow-mediated dilation of the brachial artery (BA) using high resolution continuous ECG-gated B-mode (2D) ultrasound imaging during reactive hyperemia, a state of transient increase in tissue blood flow that occurs following a brief period of ischemia, e.g., BA occlusion. BA diameter is measured at end-diastole, coincident with the R wave of a simultaneously recorded ECG. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ECOG 0-2
Key exclusion criteria (7 listed)
- Body mass index (BMI) >50 kg/m2
- Mid-upper arm circumference of arm selected for FMD testing <17 cm or >40 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 AD and BAUI testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AngioDefender | Device | AngioDefender |
| Ultrasound | Device | Brachial Artery Ultrasound Imaging |
Primary outcome
Statistical equivalence of %FMD determined by AngioDefender vs brachial artery ultrasound imaging (BAUI)
Time frame: 1 day
Deming regression analysis and Bland-Altman Plots
1 secondary outcome
Comparison of types and incidences of emergent adverse device effects
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter F Lenehan, MD PhD study director
Everist Health
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AngioDefender and Ultrasound in people with Cardiovascular Diseases, run by Everist Genomics, Inc at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statistical equivalence of %FMD determined by AngioDefender vs brachial artery ultrasound imaging (BAUI) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018.