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

Sponsor
University Hospital of Limerick (Other)
Overall Status
Recruiting
CT.gov ID
NCT05802706
Collaborator
(none)
300
Enrollment
1
Location
120
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Biomechanical Study of Diseased Human Carotid, Femoral and Abdominal Aortic Tissue
Actual Study Start Date :
Jan 1, 2016
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2026

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Secondary Outcome Measures

  1. Cardiovascular Health Critical Mass [10 years]

    To build a critical mass in cardiovascular health, an area of strategic importance for healthcare in Ireland.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Limerick Limerick Ireland

Sponsors and Collaborators

  • University Hospital of Limerick

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fiona Leahy, CNM II Research, University Hospital of Limerick
ClinicalTrials.gov Identifier:
NCT05802706
Other Study ID Numbers:
  • DVS008
First Posted:
Apr 6, 2023
Last Update Posted:
Apr 6, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Vascular Diseases

Study Results

No Results Posted as of Apr 6, 2023