Biomechanical and Microstructural Properties of Ascending Aortic Aneurysms

NCT03142074 | Recruiting

• 1 other identifier: S59521
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thoracic Aortic Aneurysms

Keywords

Improve diagnosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Investigation of correlation between rupture risk and mechanical and microstructural parameters

  6 years

Study Arms (1)

Ascending thoracic aortic aneurysm

Biomechanical and microstructural analysis of ATAA ECG-gated CT

Other: Biomechanical and microstructural analysis of ATAA; Radiation: ECG-gated CT

Interventions

Biomechanical and microstructural analysis of ATAA OTHER

Tissue collection; microstructural testing of tissue; mechanical testing of tissue .

Ascending thoracic aortic aneurysm

ECG-gated CT RADIATION

Image analysis of ECG-gated CT.

Ascending thoracic aortic aneurysm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from ATAA

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Aneurysmatic tissue

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Bart Meuris, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nele Famaey, PhD

CONTACT

016 32 89 80; nele.famaey@kuleuven.be

Amber Hendrickx, MSc

CONTACT

0492 68 42 25; amber.hendrickx@kuleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: May 5, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

BE (1)