Cardiovascular DiseasesNCT02641197
Vascular Reactivity Assessment by the AngioDefender Device -- A Precision Study
A study testing AngioDefender in people with Cardiovascular Diseases, run by Everist Genomics, Inc at 2 sites in Canada.
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. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesCanada
- Study dates
- 6 Apr 2016to 19 May 2016
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Western Ontario
London, Ontario, N6A 5A5
Hotel-Dieu Grace Healthcare
Windsor, Ontario, N9C 3Z4
About this study
Official title: Vascular Reactivity Assessment by AngioDefender -- A Repeatability and Reproducibility Study
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.
- Conditions
- Cardiovascular Diseases
- Being tested
- AngioDefender
- Keywords
- flow-mediated dilation, AngioDefender, device precision, repeatability, reproducibility, cardiovascular diseases
- 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
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.
| 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 brachial artery occlusion by a standard upper arm pneumatic blood pressure cuff. The procedure is non-invasive and does not employ ultrasound. Receives: Device: AngioDefender |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Daily x 4 consecutive days
Secondary outcomes (2)
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
Measured: Daily x 4 consecutive days
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
Measured: 4 consecutive days (maximum 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study start6 Apr 2016
- Primary completion19 May 2016
- Study completion19 May 2016
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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 Genomics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641197
- Sponsor's protocol ID
- A-1501
- Status last verified
- Jan 2018
- First submitted
- 16 Dec 2015
- Last updated
- 5 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 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Reactivity Assessment by AngioDefender -- A Repeatability and Reproducibility Study
- ClinicalTrials.gov ID
- NCT02641197
- Acronym / sponsor ID
- A-1501
- Conditions
- Cardiovascular Diseases
- Keywords
- flow-mediated dilation, AngioDefender, device precision, repeatability, reproducibility, cardiovascular diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Everist Genomics, IncIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2016 (actual)
- Primary completion
- 19 May 2016 (actual)
- Study completion
- 19 May 2016 (actual)
- First posted
- 29 Dec 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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| 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 brachial artery occlusion by a standard upper arm pneumatic blood pressure cuff. The procedure is non-invasive and does not employ ultrasound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| AngioDefenderRepeatability 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. | Device | AngioDefender |
Primary outcome
Change from baseline %flow-mediation dilation (%FMD) at 1 hour
Time frame: Daily x 4 consecutive days
Repeat AD testing of the same subject 1 hour apart on 4 consecutive days (operators and/or AD devices change each day)
2 secondary outcomes
Reproducibility of multiple %FMD determinations by AngioDefender
Time frame: Daily x 4 consecutive days
Incidence of emergent adverse device effects (ADEs) according to CTCAE v4.03
Time frame: 4 consecutive days (maximum 5 days)
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 5 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 Genomics, Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AngioDefender in people with Cardiovascular Diseases, run by Everist Genomics, Inc at 2 sites in Canada.
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 3 inclusion and 8 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 5 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 2 sites in 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?
Change from baseline %flow-mediation dilation (%FMD) at 1 hour (time frame: Daily x 4 consecutive days). 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 5 Feb 2018.