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

NCT05650892 | Unknown

• 1 other identifier: MEC-2020-0085
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thoracic Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• Male-female differences in immunohistochemical and mass spectrometry-based estrogen and testosterone receptor expression levels (and density) in the proximal aortic wall

  To investigate male-female differences in estrogen receptor (ESR-alpha and ESRbeta) and testosterone receptor (AR) tissue expression in the wall of the aortic root and ascending aorta by immunohistochemical techniques and mass spectometry. Comparisons will be made using a students t-test.

  1 year

Secondary Outcomes (1)

• Male-female differences in immunohistochemical or mass spectrometry-based sex hormone receptor expression levels (and density) in the proximal aortic wall.

  1 year

Study Arms (1)

Sample collection aortic tissue

Sample collection thoracic aorta tissue

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

Adults (≥18 years old) who will undergo or already underwent elective surgery for thoracic aortic aneurysm at Erasmus MC, Rotterdam and LUMC, Leiden.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hanneke Takkenberg: lead

Study Sites (1)

Erasmus MC

Rotterdam, 3000 CA, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Thoracic aorta (residual tissue).

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

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

Study Officials

• Hanneke Takkenberg, Prof. dr.

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: December 14, 2022
• Study Start: February 1, 2021
• Primary Completion: December 16, 2022
• Study Completion: December 31, 2023
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available upon request after a period of twelve months from the date of publication. The length of availability of IPD will depend on and therefore be based on the request of the researchers.
• Access Criteria: IPD will be shared with scientific researchers and is dependent on the research questions. The analysis and interpretation by the researcher will be checked by the project leader before any submission of the manuscript.

Locations

NL (1)