Actively Recruiting
Aortic Stiffness in Patients With Genetic Aortopathies: Intervention Analysis
Led by IRCCS Policlinico S. Donato · Updated on 2025-09-10
250
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
I
IRCCS Policlinico S. Donato
Lead Sponsor
I
Istituto Auxologico Italiano
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to study arterial stiffness in patients with thoracic ascending aortic aneurysms (TAA), including both syndromic and non-syndromic types. The study focuses on stratifying aortic risk based on arterial stiffness and comparing these measurements with the shape and blood flow characteristics of the ascending thoracic aorta. The condition is linked to genetic changes affecting the aortic wall, which can lead to aneurysms, especially in the ascending aorta. Participants will undergo a non-invasive evaluation of arterial stiffness using a device called Pulsotonometry, which measures Pulse Wave Velocity (PWV). This method is non-radioactive and helps monitor the stiffness of the aorta. The study has two groups: one with clinical or genetic diagnosis of syndromic TAA and another without such diagnosis. The Pulsotonometry assessment will be done to analyze arterial stiffness and its connection to aneurysm markers. During the study, participants will have their blood pressure and arterial stiffness measured without invasive procedures. The main outcome measure is Pulse Wave Velocity assessed over an 18-month period. Researchers will collect and compare these data to better understand arterial stiffness in this patient group. The study is observational, and participants will be monitored to provide insights into the relationship between arterial stiffness and aortic aneurysms.
CONDITIONS
Brief Title
Aortic Stiffness in Patients With Genetic Aortopathies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects with ascending aortic aneurysm (AAT), either syndromic or non-syndromic
- Signed informed consent
You will not qualify if you...
- Patients with early menopause and/or osteoporosis, rheumatic heart disease, or active malignant tumors
- Patients with acute or chronic inflammatory conditions such as chronic liver disease, chronic renal insufficiency, or thyroid diseases
- Positive tests for HIV, HCV, HBsAg, or SARS-CoV-2
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 18 months
Participants undergo non-invasive assessment of aortic stiffness using pulse wave velocity measurements.
Periodic visits during the 18 months for pulse wave velocity measurements
Duration - Up to 18 months
Participants are monitored to evaluate changes in aortic stiffness and other related aneurysm markers over time.
Follow-up visits as scheduled during the monitoring period
Trial Site Locations
Total: 1 location
1
IRCCS Policlinico San Donato
San Donato Milanese, Lombardy, Italy, 20097
Actively Recruiting
Research Team
A
Alessandro Pini, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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