New Advanced Vascular Imaging Ultrasound Protocols
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorMario Negri Institute for Pharmacological Research
About this trial
This is a single-center observational study aimed at setting up and testing new ultrasound vascular imaging protocols, conducted exclusively for research purposes. The study will perform US examinations in 60 subjects. The subjects enrolled in the study will be examined the first time and will then provide consent to be examined again in the future if needed.
The primary aim of this study is to set-up and test new advanced US protocol for the arm and cerebral blood vessels
The secondary objectives will be:
* Define ranges of normality/reference values of US-based parameters to be compared with pathological values. * Evaluate the repeatability and reproducibility of the acquired US measurements. * Evaluate the correlation between age and the acquired US measurements. * Evaluate the correlation between gender and the acquired US measurements.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Provision of informed consent prior to any study specific procedures
Female and/or male aged between 18 and 75 years
No previous history of kidney or cerebral disease and no pathologies that might have affected the vascular system
Disqualifiers
Previous history of kidney or cerebral disease or pathologies that might have affected the vascular system
Legal incapacity, limited legal capacity, intellectual disability, uncooperative attitude or any other evidence that the subject will not be able to understand the study aims and procedures
Trial population
Participation in this study will be proposed to subjects with no previous history of kidney or cerebral disease, and no pathologies that might have affected the vascular system (hypertension, diabetes). Sixty subjects will be studied, 30 females and 30 males. For both genders, they must be equally distributed within 3 age-groups: 18-40 years, 41-55 years and 56-75 years.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
US acquisitions
Diagnostic testUS acquisition from two anatomical regions i.e., the non-dominant arm and the neck.
Treatment groups
60 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Males, age group 11 intervention
Group B: Males, age group 21 intervention
Group C: Males, age group 31 intervention
Group D: Female, age group 11 intervention
Group E: Females, age group 21 intervention
Group F: Females, age group 31 intervention
Trial outcomes
Primary outcomes
1
Non-dominant arm US acquisitions
Diameter of the radial artery in the middle forearm, brachial artery over the elbow, ulnar artery in the middle forearm and Cephalic vein in the middle forearm (mm)
Time frame
US acquisition at enrollment2
Non-dominant arm US acquisitions
Flow volume of the radial artery in the middle forearm, brachial artery over the elbow, ulnar artery in the middle forearm (ml/min)
Time frame
US acquisition at enrollment3
Non-dominant arm US acquisitions
Thickness of the radial artery and cephalic vein wall (mm)
Time frame
US acquisition at enrollment4
Non-dominant arm US acquisitions
Stiffness of the radial artery and cephalic vein wall (%)
Time frame
US acquisition at enrollmentSponsors and contacts
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Source ClinicalTrials.gov