New Advanced Vascular Imaging Ultrasound Protocols
RESONA-SETTING
Unlock the Power of Resona 9 Ultrasound Machine: an Observational Study to Set-up and Test New Advanced Vascular Imaging Protocols
1 other identifier
observational
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2025
CompletedFirst Posted
Study publicly available on registry
February 24, 2025
CompletedStudy Start
First participant enrolled
May 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
September 5, 2025
August 1, 2025
1.8 years
February 3, 2025
August 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
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)
US acquisition at enrollment
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)
US acquisition at enrollment
Non-dominant arm US acquisitions
Thickness of the radial artery and cephalic vein wall (mm)
US acquisition at enrollment
Non-dominant arm US acquisitions
Stiffness of the radial artery and cephalic vein wall (%)
US acquisition at enrollment
Non-dominant arm US acquisitions
Time averaged velocity (TAV) of the radial artery in the middle forearm, brachial artery over the elbow and ulnar artery in the middle forearm (cm/s)
US acquisition at enrollment
Neck carotid (right and left) US acquisitions
Diameter of the common carotid artery, internal carotid artery, external carotid artery and vertebral arteries (mm)
US acquisition at enrollment
Neck carotid (right and left) US acquisitions
Flow volume of the common carotid artery, internal carotid artery, external carotid artery and vertebral arteries (ml/min)
US acquisition at enrollment
Neck carotid (right and left) US acquisitions
Thickness of the wall of the common carotid (mm)
US acquisition at enrollment
Neck carotid (right and left) US acquisitions
Stiffness of the wall of the common carotid (%)
US acquisition at enrollment
Neck carotid (right and left) US acquisitions
Time averaged velocity (TAV) of the common carotid artery, internal carotid artery, external carotid artery and vertebral arteries (cm/s)
US acquisition at enrollment
Study Arms (6)
Males, age group 1
Male subjects aged 18-40 years
Males, age group 2
Male subjects aged 41-55 years
Males, age group 3
Male subjects aged 56-75 years
Female, age group 1
Female subjects aged 18-40 years
Females, age group 2
Female subjects aged 41-55 years
Females, age group 3
Female subjects aged 56-75 years
Interventions
US acquisition from two anatomical regions i.e., the non-dominant arm and the neck.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Research Centre for Rare Diseases Aldo e Cele Daccò
Ranica, BG, 24020, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Giuseppe Remuzzi, M.D.
Istituto Di Ricerche Farmacologiche Mario Negri
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2025
First Posted
February 24, 2025
Study Start
May 9, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
September 5, 2025
Record last verified: 2025-08