Measuring aortic wall strength and thickness in ascending aortic aneurysms
Strength Tracking From Wall Tichness Over Aortic Biomechanics
IRCCS Policlinico S. Donato · NCT07453251
This project tests whether measuring the strength and thickness of removed ascending aortic tissue can help predict rupture risk for patients having surgery for aortic root or ascending aortic aneurysms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Policlinico S. Donato (other) |
| Locations | 1 site (San Donato Milanese, MI) |
| Trial ID | NCT07453251 on ClinicalTrials.gov |
What this trial studies
This observational project analyzes resected ascending aortic tissue from patients undergoing surgery for aortic root or ascending aortic aneurysms. Samples undergo standardized mechanical testing (tensile strength, stiffness) and wall-thickness measurement in the lab. Those biomechanical results will be compared with clinical and imaging data such as aortic diameter and valve morphology to look for correlations. The goal is to standardize measurements and determine whether biomechanical data add information about aortic fragility beyond diameter alone.
Who should consider this trial
Good fit: Adults scheduled for elective cardiac surgery to remove an ascending aortic or aortic root aneurysm who can provide written informed consent are ideal candidates.
Not a fit: Patients who have had prior cardiac surgery or who present with acute aortic conditions (such as acute dissection or intramural hematoma) are excluded and would not receive benefit from participating.
Why it matters
Potential benefit: If successful, this work could provide surgeons an extra objective measure of aortic fragility to help time operations and counsel patients.
How similar studies have performed: Previous laboratory and computational studies have measured aortic wall biomechanics and reported links to tissue fragility, but these findings have not yet become widely used clinical decision tools.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing cardiac surgery for either aortic root and/or ascending aortic aneurysms; • Patients that have received, understood and signed the written informed consent for this study. Exclusion Criteria: * Patients that have already undergone previous cardiac surgery; • Patients that present with acute aortic pathologies, such as acute aortic dissection or intramural hematoma.
Where this trial is running
San Donato Milanese, MI
- IRCCS Policlinico San Donato — San Donato Milanese, MI, Italy (RECRUITING)
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.
Conditions: Aneurysm Aortic, Aneurysm Aortic Root, aortic aneurysm, bicuspid aortic valve, tricuspid aortic valve, tensile testing, aortic strength, aortic rupture