Vascular Reactivity Assessment by the AngioDefender Device -- A Precision Study
NCT ID: NCT02641197
Last Updated: 2018-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2016-04-06
2016-05-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Brachial Artery Ultrasound Imaging: A Repeatability Study
NCT02682576
The Assessment of Large and Small Artery Elasticity for the Early Detection of Cardiovascular Disease
NCT02863211
The Association Between Systemic Microvascular Endothelial Function and Coronary Physiology Indexes
NCT05864729
Coronary Artery Plaque Burden in Stable Angina and Non-obstructive Coronary Artery Disease
NCT04009421
68 Ga-NODAGA-E[c(RGDγK)]2: Positron Emission Tomography Tracer for Imaging of Angiogenesis in Ischemic Heart Disease
NCT03505346
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AngioDefender
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Everist Genomics, Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Peter F Lenehan, MD PhD
Role: STUDY_DIRECTOR
Everist Genomics, Inc
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Western Ontario
London, Ontario, Canada
Hotel-Dieu Grace Healthcare
Windsor, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A-1501
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.