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

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• Identification of extreme aortic wall fragility in relation to demographic or pathological characteristics of the enrolled patients. — Perioperative (Within 24 hours from surgery)
  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.

Trial sites (1)

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