Measuring the shape and strength of the ascending aorta in patients having heart surgery
Official title: 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
Run by Fondazione IRCCS Policlinico San Matteo di Pavia · NCT07422129 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Lombardy) |
| Status | Recruiting |
| Started | March 24, 2015 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | February 19, 2026 |
| Trial ID | NCT07422129 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.