NCT07422129|Recruiting
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Sponsor study identifier
observational
250
1 country
1
Study Start
March 24, 2015
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 24, 2015
Actual (reported)February 3, 2026
Actual (reported)February 19, 2026
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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)
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)
Diseased aorta included patients with chronic aortic aneurysm and patients with aortic dissection. Control group included non diseased aorta undergoing surgery for heart transplantation.
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.
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Lombardy, 27100, Italy
First Submitted
February 3, 2026
First Posted
February 19, 2026
Study Start
March 24, 2015
Actual (reported)Primary Completion
December 31, 2026
EstimatedMatrix Aging and Aneurysm
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 19, 2026
Record last verified: 2026-02
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