Thoracic Aortic AneurysmsNCT03142074
Biomechanical and Microstructural Properties of Ascending Aortic Aneurysms
An observational study of Thoracic Aortic Aneurysms, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Aortic Aneurysms
- What is being tested?
- Biomechanical and microstructural analysis of ATAA and ECG-gated CT
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2017to Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from ATAA
Who may be able to join
- Patients suffering from thoracic aortic aneurysms (ATAA), asymptomatic or symptomatic.
- Patients with ruptured ATAA undergoing an emergency surgery.
- Signed informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, Vlaams Brabant, 3000
Bart Meuris, MD, 016 34 42 60, bart.meuris@kuleuven.be
About this study
Official title: 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.
Read the 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.
- Conditions
- Thoracic Aortic Aneurysms
- Being tested
- Biomechanical and microstructural analysis of ATAA, ECG-gated CT
- Keywords
- Improve diagnosis
- Medical subject headings
- Aortic Aneurysm, Thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomechanical and microstructural analysis of ATAAOther
Tissue collection; microstructural testing of tissue; mechanical testing of tissue .
ECG-gated CTRadiation
Image analysis of ECG-gated CT.
| Study group | Role | What they receive |
|---|---|---|
| Ascending thoracic aortic aneurysm | Biomechanical and microstructural analysis of ATAA
ECG-gated CT Receives: Other: Biomechanical and microstructural analysis of ATAA; Radiation: ECG-gated CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, ...)
Measured: 6 years
Secondary outcomes (1)
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)
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study startJan 2017
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Aortic AneurysmsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bart Meuris, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142074
- Sponsor's protocol ID
- S59521
- Status last verified
- Jun 2024
- First submitted
- 6 Oct 2016
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIOMECHANICAL AND MICROSTRUCTURAL PROPERTIES OF THE AORTIC WALL: A Pilot Study in Patients Undergoing Surgery for Ascending Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT03142074
- Acronym / sponsor ID
- S59521
- Conditions
- Thoracic Aortic Aneurysms
- Keywords
- Improve diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ascending thoracic aortic aneurysm | – | Other: Biomechanical and microstructural analysis of ATAA, Radiation: ECG-gated CTBiomechanical and microstructural analysis of ATAA ECG-gated CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from ATAA
Key inclusion criteria (3 listed)
- Patients suffering from thoracic aortic aneurysms (ATAA), asymptomatic or symptomatic.
- Patients with ruptured ATAA undergoing an emergency surgery.
- Signed informed consent.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomechanical and microstructural analysis of ATAATissue collection; microstructural testing of tissue; mechanical testing of tissue . | Other | Ascending thoracic aortic aneurysm |
| ECG-gated CTImage analysis of ECG-gated CT. | Radiation | Ascending thoracic aortic aneurysm |
Primary outcome
Data collection of patients suffering from thoracic aortic aneurysms
Time frame: 6 years
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, ...)
1 secondary outcome
Investigation of correlation between rupture risk and mechanical and microstructural parameters
Time frame: 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart Meuris, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Aortic Aneurysms, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nele Famaey, PhD (016 32 89 80, nele.famaey@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data collection of patients suffering from thoracic aortic aneurysms (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.