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NCT05802706 Clinical Trial

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

Vascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05802706
Other study ID # DVS008
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date January 1, 2026

Study information
Verified date April 2024
Source University Hospital of Limerick
Contact Fiona Leahy, MSc
Phone 061 301111
Email fionac.leahy@hse.ie
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date January 1, 2026
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• No intervention.
No intervention.

Locations
Country Name City State
Ireland University Hospital Limerick Limerick

Sponsors (1)
Lead Sponsor Collaborator
University Hospital of Limerick

Country where clinical trial is conducted

Ireland, 

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