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Comprehensive Assessment of Morphometric, Functional, Biomechanical and Biological Interactions Between Atherosclerotic Plaque and Platelets Within the Stenosed Coronary Artery

NCT06275399 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 105

Last updated 2024-02-23

No results posted yet for this study

Summary

The main objective of the present study is to verify, in vivo, whether shear forces computed solely based on coronary angiography and computational fluid dynamics (CFD) techniques are associated with the biomarkers indicating the prothrombotic tendency of circulating blood in situ - distally and proximally to the coronary stenosis. The study will prospectively assess the relationship between i) the value and distribution of shear rate and shear stress (SS) estimated using three-dimensional angiography and CFD techniques, and ii) atherosclerotic plaque characteristics as assessed by optical coherence tomography (OCT), iii) functional parameters of diseased vessels assessed by vessel fractional flow reserve (vFFR), and iv) in situ platelet activation, as expressed by platelet-derived microvesicles (pMVs) and small extracellular vesicles (sEVs), platelet aggregometry and other serum prothrombotic or inflammatory biomarkers sampled within the coronary artery.

Conditions

Interventions

DIAGNOSTIC_TEST

OCT examination

OCT examination for precise evaluation of plaque morphology within the coronary stenosis.

DIAGNOSTIC_TEST

Blood sampling

Blood sampling directly from coronary artery (proximal and distal segment) arteries

DIAGNOSTIC_TEST

Assessment of vFFR and shear stress parameters

The procedure is based on non-invasive assessment of vFFR and shear stress parameters with dedicated software, deriving parameters directly from coronary angiography with the calculation based on the computational fluid dynamics

Sponsors & Collaborators

  • National Science Centre, Poland

    collaborator OTHER_GOV

  • University College, London

    collaborator OTHER

  • Queen Mary University of London

    collaborator OTHER

  • Medical University of Warsaw

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-21
Primary Completion
2025-07-21
Completion
2026-07-21

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06275399 on ClinicalTrials.gov