Evaluating aortic stiffness in patients with genetic aortopathies
Aortic Stiffness in Patients With Genetic Aortopathies: Intervention Analysis
This study is testing how stiff the arteries are in people with aortic aneurysms caused by genetic conditions to see if it helps understand their risk better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Sex | All |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 1 site (San Donato Milanese, Lombardy) |
| Trial ID | NCT05715203 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess arterial stiffness in patients with thoracic ascending aortic aneurysms, both syndromic and non-syndromic. Participants will undergo non-invasive evaluations to measure blood pressure and arterial stiffness using Pulse Wave Velocity (PWV). The study seeks to stratify aortic risk based on these measurements and compare them with morphological and hemodynamic features of the ascending thoracic aorta. The findings could provide insights into the relationship between aortic stiffness and aneurysm markers.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with thoracic ascending aortic aneurysms, whether syndromic or non-syndromic.
Not a fit: Patients with conditions such as early menopause, osteoporosis, rheumatic heart disease, active malignancies, or acute/chronic inflammatory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of aortic stiffness and its implications for managing patients with genetic aortopathies.
How similar studies have performed: While there have been studies correlating PWV in specific conditions like Marfan syndrome, evaluations of aortic stiffness in syndromic TAA are limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects with AAT, either syndromic or non syndromic; * Signed informed consent Exclusion Criteria: * Patients with early menopause and/or osteoporosis, rheumatic heart disease and active malignant tumours; * Patients with acute and chronic inflammatory conditions such as: chronic liver disease, chronic renal insufficiency and diseases affecting the thyroid system; * Seropositivity to HIV, HCV, HBsAg and SARS-CoV-2; * Pregnancy
Where this trial is running
San Donato Milanese, Lombardy
- IRCCS Policlinico San Donato — San Donato Milanese, Lombardy, Italy (Recruiting)
Study contacts
- Principal investigator: Alessandro Pini — Cardiovascular-Gentic Centre, IRCCS Policlinico San Donato
- Study coordinator: Alessandro Pini, MD
- Email: alessandro.pini@grupposandonato.it
- Phone: +390252774705
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.