Male-female Differences in Immunohistological and Biomechanical Properties of the Thoracic Aorta

NCT ID: NCT05650892

Last Updated: 2023-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2023-12-31

Brief Summary

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Thoracic aortic aneurysms (TAA) result from progressive dilatation of the thoracic aorta and confer a risk for aortic dissection or rupture, which is associated with significant morbidity and mortality. In the Netherlands there are an estimated 200.000 adults with TAA, and annually 600 deaths after aortic dissection or rupture. There are clear differences in the incidence of TAA between men and women, with a higher incidence in men. Little is known on possible differences in outcome between male and female patients with Thoracic Aortic Aneurysm (TAA). Aortic disease is thought to affect men more frequently than women, and aortic growth is different between men and women. Current data suggest that women are at an increased risk of both dying from aortic dissection and having aorta-related complications compared to men (1). The mechanisms for these male-female difference in TAA outcome remain, however, unclear. The timing of preventive surgery is now not different for men and women, but gender-based cut-off values for maximal aortic diameter based on differences in vessel wall composition might be needed.

Detailed Description

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Thoracic aortic aneurysms (TAA) result from progressive dilatation of the thoracic aorta and confer a risk for aortic dissection or rupture, which is associated with significant morbidity and mortality. In the Netherlands there are an estimated 200.000 adults with TAA, and annually 600 deaths after aortic dissection or rupture. There are clear differences in the incidence of TAA between men and women, with a higher incidence in men. Little is known on possible differences in outcome between male and female patients with Thoracic Aortic Aneurysm (TAA). Aortic disease is thought to affect men more frequently than women, and aortic growth is different between men and women. Current data suggest that women are at an increased risk of both dying from aortic dissection and having aorta-related complications compared to men(1). However, the mechanisms for these male-female differences in TAA outcome remain unclear. The timing of preventive surgery is not different for men and women, but gender-based cut-off values for maximal aortic diameter based on differences in vessel wall composition might be beneficial for outcome.

The current research project aims to implement male-female specific insights into aortic root and ascending aorta characteristics into clinical practice, allowing better identification of high risk Thoracic Aortic Aneurysm (TAA) patients and better timing of intervention. With this study the investigators aim to obtain insight into male-female differences in the immunohistological and biomechanical properties of the thoracic aortic wall. In order to reveal possible mechanisms for male-female differences in TAA.

Conditions

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Thoracic Aortic Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sample collection aortic tissue

Sample collection thoracic aorta tissue

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult patients (≥ 18 years old) who have a thoracic aortic aneurysm and are scheduled for elective thoracic aortic surgery in the Erasmus MC or the LUMC.

Exclusion Criteria

* Patients with a known connective tissue disease (e.g. Marfan Syndrome and Ehlers-Danlos syndromes).
* Connective tissue disease,
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanneke Takkenberg

OTHER

Sponsor Role lead

Responsible Party

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Hanneke Takkenberg

Prof. dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hanneke Takkenberg, Prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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Erasmus MC

Rotterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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MEC-2020-0085

Identifier Type: -

Identifier Source: org_study_id

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