Biomechanical and Microstructural Properties of Ascending Aortic Aneurysms

BIOMECHANICAL AND MICROSTRUCTURAL PROPERTIES OF THE AORTIC WALL: A Pilot Study in Patients Undergoing Surgery for Ascending Aortic Aneurysms

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracic Aortic Aneurysms
• Intervention / Treatment: Other: Biomechanical and microstructural analysis of ATAA; Radiation: ECG-gated CT

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: Nele Famaey, PhD; Phone Number: 016 32 89 80; Email: nele.famaey@kuleuven.be
• Study Contact Backup: Name: Amber Hendrickx, MSc; Phone Number: 0492 68 42 25; Email: amber.hendrickx@kuleuven.be

Study Locations

• Belgium
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • Recruiting
      • UZ Leuven
      • Contact: Bart Meuris, MD; Phone Number: 016 34 42 60; Email: bart.meuris@kuleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from ATAA

Description

Inclusion Criteria:

• Patients suffering from thoracic aortic aneurysms (ATAA), asymptomatic or symptomatic.
• Patients with ruptured ATAA undergoing an emergency surgery.
• Signed informed consent.

Exclusion Criteria:

• Patients with ruptured ATAA due to trauma.
• The presence of any aneurysm feature that will prevent the collection of tissue samples suitable for the biomechanical and microstructural studies.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ascending thoracic aortic aneurysm; Biomechanical and microstructural analysis of ATAA ECG-gated CT	Other: Biomechanical and microstructural analysis of ATAA; Tissue collection; microstructural testing of tissue; mechanical testing of tissue .; Radiation: ECG-gated CT; Image analysis of ECG-gated CT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, ...)	6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	6 years

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Bart Meuris, PhD, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 6, 2016
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Improve diagnosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic; Aneurysm, Ascending Aorta
• Other Study ID Numbers: S59521

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No