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

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.

Study Overview

• Status: Recruiting
• Conditions: Vascular Diseases
• Intervention / Treatment: Other: No intervention.

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Fiona Leahy, MSc; Phone Number: 061 301111; Email: fionac.leahy@hse.ie

Study Locations

• Ireland
  • Limerick, Ireland
    • Recruiting
    • University Hospital Limerick
    • Contact: Fiona Leahy, MSc; Phone Number: 061 301111; Email: fionac.leahy@hse.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients eligible for peripheral endarterectomy of the carotid/femoral artery or abdominal aortic aneurysm surgery to remove artery blockage will be invited to take part in this study with no restrictions on patient type.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calcification feature classification	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.	10 years
Biomarker Analysis	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.	10 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital of Limerick

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: March 24, 2023
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: DVS008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No