An observational study in Thoracic Aortic Aneurysms, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-01.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational
An aortic aneurysm (thoracic or abdominal) is a permanent dilatation of the aorta caused by weakening in the arterial wall. The feared complication is aortic rupture or dissection, leading to potentially lethal aortic bleeding and associated with mortality rates up to 95%. The current diagnosis criteria do not suffice, therefore the goal of this study is the development of an improved biomechanics-based and microstructural-based diagnostic tool.
An aortic aneurysm (thoracic or abdominal) is a permanent dilatation of the aorta caused by weakening in the arterial wall. The feared complication is aortic rupture or dissection, leading to potentially lethal aortic bleeding and associated with mortality rates up to 95%. Diagnosis of the aneurysm and especially its risk of rupture or dissection is highly challenging. If the aneurysm diameter and/or growth rate exceed a specific threshold (respectively 55 mm and 1 cm/year), a highly invasive and dangerous surgery is performed. However, several studies have shown no correlation between the maximum transverse diameter and the risk of rupture or dissection. Since aneurysm rupture is associated with multiple aortic tissue properties, both biomechanics-based and microstructurally-based criteria can be a promising alternative.
The overall goal of this trial is a biomechanical and microstructural analysis of aneurysms to improve the diagnostic criterion for aneurysm rupture risk. Within this goal, two scientific objectives can be distinguished. Firstly, a highly unique dataset with patient data allowing the development of an improved diagnostic tool will be created. This dataset will contain an abundance of relevant parameters such as patient characteristics, geometry, material properties and biomechanical and microstructural characteristics. The biomechanical and microstructural data will be obtained by the analysis of resected aneurysmal tissue and by dynamic imaging (4D CT). 4D CT scans are a series of ECG-gated scans that are taken at specified intervals in the cardiac circle. The second objective is to create a personalized diagnostic tool. An aneurysm rupture risk criteria based on geometry as well as biomechanical and microstructural properties is expected to be significantly more reliable than the current criteria. More specifically, a correlation between patient characteristics that can be measured non-invasively and the aneurysm rupture risk is searched for.
960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.
This study's planned enrollment of 180 is above the median of 151 across 443 observational studies indexed under Aneurysm.
Browse Aneurysm studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
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Patients suffering from ATAA
Exclusion Criteria:
Biomechanical and microstructural analysis of ATAA ECG-gated CT
Other: Biomechanical and microstructural analysis of ATAA · Radiation: ECG-gated CT
Tissue collection; microstructural testing of tissue; mechanical testing of tissue .
Image analysis of ECG-gated CT.
Data collection of patients suffering from thoracic aortic aneurysms
General information (age, gender, height, weight, BMI); medicinal usage (beta-blockers, ACE inhibitors, statins, angiotensin receptor blockers, ...); cardiovascular risk factors (smoking, hypertension, dyslipidemia, diabetes, atrial fibrillation); cardiovascular properties (tricuspid aortic valve, inherited aortopathies, abdominal aortic aneurysm, prior open heart surgery, ...)
Time frame: 6 years
Investigation of correlation between rupture risk and mechanical and microstructural parameters
Mechanical properties (linear and non-linear stiffness) and histological properties (elastin fraction, collagen fraction, inflammation status, wall thickness)
Time frame: 6 years
Plan to share: Undecided
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Universitaire Ziekenhuizen KU Leuven