The Biomechanical Study of Diseased Human Carotid, Femoral and Abdominal Aortic Tissue

Recruiting

• Conditions: Vascular Diseases

• Registration Number: NCT05802706
• Lead Sponsor: University Hospital of Limerick

Brief Summary

This cross-sectional study aims to ascertain the mechanical properties of human carotid/femoral atherosclerotic plaque and abdominal aortic aneurysm tissue and correlate tissue mechanics with novel blood-based biomarkers of cardiovascular calcification.

Detailed Description

The study is a non-randomised, controlled, cross-sectional study of diseased human carotid, femoral and abdominal aortic tissue.

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2023-03-24
• Study First Submitted QC: 2023-03-24
• Study First Posted: 2023-04-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients with arterial plaque undergoing treatment where the plaque tissue will be surgically removed as per the usual peripheral endarterectomy procedure.
• Able to provide informed consent.

Exclusion Criteria

• Patients that are unable to give informed consent.
• Seriously ill/unconscious patients.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biomarker Analysis	10 years	Identification of novel biomarkers of vascular calcification could potentially be used as a predictive tool to highlight those at greatest risk of adverse peri-operative events, to allow for tailored medical treatment approaches and to stream-line patient care and improve patient outcomes.
Calcification feature classification	10 years	Identification of particular calcification features of plaque tissue and their influence on mechanical properties which may help clarify the success of stenting in certain patient cohorts compared to others and elucidate the procedural risk of endovascular treatments in plaque with certain calcification types.

Secondary Outcome Measures

Name	Time	Method
Cardiovascular Health Critical Mass	10 years	To build a critical mass in cardiovascular health, an area of strategic importance for healthcare in Ireland.

Trial Locations

Locations (1)

University Hospital Limerick; 🇮🇪 Limerick, Ireland