The Biomechanical Study of Diseased Human Carotid, Femoral and Abdominal Aortic Tissue
1 other identifier
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 24, 2023
CompletedFirst Posted
Study publicly available on registry
April 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
April 17, 2025
April 1, 2025
11 years
March 24, 2023
April 14, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Cardiovascular Health Critical Mass
10 years
Interventions
No intervention.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Patients that are unable to give informed consent.
- Seriously ill/unconscious patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Limerick
Limerick, Limerick, Ireland
Biospecimen
Arterial plaque tissue is retained following the routine endarterectomy procedure.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- CNM II Research
Study Record Dates
First Submitted
March 24, 2023
First Posted
April 6, 2023
Study Start
January 1, 2016
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
April 17, 2025
Record last verified: 2025-04