Measuring the shape and strength of the ascending aorta in patients having heart surgery
Multidisciplinary Analysis by Morphological and Mechanical Evaluation of the Aortic Wall in Patients With Aortic Disease, Undergoing Aortic Cardiac Surgery, vs Patients Without Aortic Disease
We will test whether direct measurements of the aortic wall's mechanical properties taken during heart surgery can better characterize rupture or dissection risk in people with ascending aortic aneurysm by comparing them to patients undergoing heart transplantation without known aortic disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Lombardy) |
| Trial ID | NCT07422129 on ClinicalTrials.gov |
What this trial studies
This observational project collects samples of the ascending aorta removed during routine cardiac operations and sends leftover tissue for anonymous mechanical testing at the University of Pavia's engineering department. Patients undergoing ascending aorta replacement form the primary group, while patients undergoing heart transplantation or donor aortas serve as controls. Specimen collection follows standard surgical practice and does not change clinical care or decision-making, and patients with high biological hazard infections (HCV/HIV) are excluded. Results will compare morphological and mechanical properties across groups to clarify links between clinical features and aortic wall behavior.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for cardiac surgery that includes ascending aorta replacement or patients undergoing heart transplantation at the enrolling center who can give informed consent and are not HCV/HIV positive.
Not a fit: People not undergoing cardiac surgery at the center or those excluded for infectious risk (HCV/HIV) are unlikely to benefit from or be eligible for this protocol.
Why it matters
Potential benefit: If successful, the findings could add direct mechanical information to diameter-based criteria and help improve decisions about timing of surgery to prevent rupture or dissection.
How similar studies have performed: Prior work has suggested clinical factors may correlate with weaker aortic tissue but a direct in vivo mechanical characterization and the specific comparison with transplant patients is novel and not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing surgery including ascending aorta replacement at our Department and/or heart transplantation Exclusion Criteria: * Patients with biological hazard (HBC/HIV +)
Where this trial is running
Pavia, Lombardy
- Fondazione IRCCS Policlinico San Matteo di Pavia — Pavia, Lombardy, Italy (Recruiting)
Study contacts
- Study coordinator: Pasquale Totaro, MD
- Email: p.totaro@matteo.pv.it
- Phone: 3283678762
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.