Cardiovascular DiseasesNCT02682576
Brachial Artery Ultrasound Imaging: A Repeatability Study
A study testing Brachial artery ultrasound imaging in people with Cardiovascular Diseases, run by Everist Genomics, Inc at 2 sites in United States.
Trial summary
The objective of the study is to define the analytical repeatability of quantifying flow-mediated dilation of the brachial artery using brachial artery ultrasound imaging using upper arm cuff occlusion. 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?
- Brachial artery ultrasound imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2016to 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 (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 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.
United States2 sites
Yale University Prevention Research Center
Derby, Connecticut, 06418
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
The objective of the study is to define the analytical repeatability of quantifying flow-mediated dilation of the brachial artery using brachial artery ultrasound imaging using upper arm cuff occlusion.
- Conditions
- Cardiovascular Diseases
- Being tested
- Brachial artery ultrasound imaging
- Keywords
- brachial artery ultrasound imaging, flow-mediated dilation, endothelium
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brachial artery ultrasound imagingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Brachial artery ultrasound imaging | Experimental | Brachial artery ultrasound imaging is a non-invasive procedure for detecting endothelial dysfunction by measuring the flow-mediated dilation of the brachial artery using high resolution continuous electrocardiogram-gated B-mode (2D) ultrasound imaging during reactive hyperemia. Receives: Procedure: Brachial artery ultrasound imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline % flow-mediated dilation (%FMD) at 1 hour
Repeat brachial artery ultrasound imaging of the same subject after 1 hour using the same operator and vascular ultrasound equipment
Measured: 1 hour
Secondary outcomes (1)
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: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2016
- Study completionMay 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
- 21 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 chair, Everist Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682576
- Sponsor's protocol ID
- A-1601
- Status last verified
- Feb 2017
- First submitted
- 9 Feb 2016
- Last updated
- 8 Feb 2017
- 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 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brachial Artery Ultrasound Imaging: A Repeatability Study
- ClinicalTrials.gov ID
- NCT02682576
- Acronym / sponsor ID
- A-1601
- Conditions
- Cardiovascular Diseases
- Keywords
- brachial artery ultrasound imaging, flow-mediated dilation, endothelium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Everist Genomics, IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 15 Feb 2016 (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 the study is to define the analytical repeatability of quantifying flow-mediated dilation of the brachial artery using brachial artery ultrasound imaging using upper arm cuff occlusion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brachial artery ultrasound imaging | Experimental | Procedure: Brachial artery ultrasound imagingBrachial artery ultrasound imaging is a non-invasive procedure for detecting endothelial dysfunction by measuring the flow-mediated dilation of the brachial artery using high resolution continuous electrocardiogram-gated B-mode (2D) ultrasound imaging during reactive hyperemia. |
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 (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 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 |
|---|---|---|
| Brachial artery ultrasound imaging | Procedure or surgery | Brachial artery ultrasound imaging |
Primary outcome
Change from baseline % flow-mediated dilation (%FMD) at 1 hour
Time frame: 1 hour
Repeat brachial artery ultrasound imaging of the same subject after 1 hour using the same operator and vascular ultrasound equipment
1 secondary outcome
Incidence of emergent adverse device effects (ADEs) according to CTCAE v4.03
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 8 Feb 2017.
- 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 chair
Everist Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brachial artery ultrasound imaging in people with Cardiovascular Diseases, run by Everist Genomics, Inc at 2 sites in United States.
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 8 Feb 2017. 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 United States. 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-mediated dilation (%FMD) at 1 hour (time frame: 1 hour). 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 8 Feb 2017.