Multidisciplinary Analysis by Morphological and Mechanical Evaluation of the Aortic Wall in Patients Undergoing Cardiac Surgery.

NCT07422129 | Recruiting

• 1 other identifier: APA
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical indication in patients suffering from Ascending aorta aneurysm is currently based mainly on the maximum diameter of the aortic dilatation and on the yearly growth rate. Several clinical preoperative patients characteristics have been, potentially, correlated to impaired mechanical characteristics of aortic wall, and therefore to an increased risk of rupture and or dissection. On other hands, such suppositions have been never confirmed, as a full characterization of the mechanical behaviour of the ascending aortic tissue, especially in case of aneurysm, has not been fully clarified yet. Objective of this observational study is to better elucidate, using direct in vivo evaluation, the mechanical characteristics of the aortic wall in patients with ascending aorta diseases. Our study will have a further peculiar characteristic as we have the intention of compare such mechanical characteristics to those of patients, without known aortic diseases, undergoing heart transplantation. Potential correlation between, directly measured mechanical characteristics of the aortic wall, and preoperative parameters (anagraphic patients characteristics, clinical data and diagnostic tests) will be also investigated.

Conditions

Aortic Aneurysm; Aortic Aneurysm and Dissection

Outcome Measures

Primary Outcomes (1)

• Identification of extreme aortic wall fragility in relation to demographic or pathological characteristics of the enrolled patients.

  The execution of the above tests, and the following analysis and post-processing of the tests response will allow the characterization of ultimate mechanical properties using three main parameters: 1. Peak Strein (the maximum strein before specimen rupture) 2. Peak Stress (the maximum stress before specimen rupture) 3. Maximum Elastic Modulus (the maximum slope of the stress-strain curve The identification of extreme aortic wall fragility will be based primarily on extreme values of the first two parameters (\<25th percentile). For the third parameter, both extreme values (\<25th and \>75th percentile) will be considered. As a further parameter of fragility, an abnormal increase in intra-patient variability will also be considered, in case of the possibility of multiple tests.

  Perioperative (Within 24 hours from surgery)

Other Outcomes (2)

• Ex-vivo evaluation of mechanical properties of aortic wall in patients with and without aortic diseases undergoing cardiac surgery procedure.

  Perioperative (within 24 hours from surgery)

• Ex vivo evaluation of aortic wall mechanical characteristics in patients with and without aortic disease.

  Perioperative (Without 24 hours from surgery)

Study Arms (1)

2 main groups: Diseased Aorta and non-diseased aorta

Diseased aorta included patients with chronic aortic aneurysm and patients with aortic dissection. Control group included non diseased aorta undergoing surgery for heart transplantation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The primary study population consisted of patients referred for ascending aortic/aortic root dilation surgery. The study evolved to include control groups including patients with acute aortic dissection and patients without aortic disease undergoing heart transplantation.

You may qualify if:

• Patients undergoing surgery including ascending aorta replacement at our Department and/or heart transplantation

You may not qualify if:

• Patients with biological hazard (HBC/HIV +)

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Lombardy, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm; Aortic Dissection

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome

Central Study Contacts

Pasquale Totaro, MD

CONTACT

3283678762; p.totaro@matteo.pv.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 19, 2026
• Study Start: March 24, 2015
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

IT (1)