RecruitingNCT06275399

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

Comprehensive Assessment of Morphometric, Functional, Biomechanical, and Biological Interactions Between Atherosclerotic Plaque and Blood Platelets Within the Stenosed Coronary Artery in Vivo: a Prospective Study


Sponsor

Medical University of Warsaw

Enrollment

105 participants

Start Date

Jul 21, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Chronic coronary syndrome
  • Angiographically confirmed coronary stenosis (30% - 90%)
  • Amenable to OCT imaging

Exclusion Criteria10

  • Cardiogenic shock
  • ST-segment elevation or non-ST-segment elevation myocardial infarction
  • Active bleeding
  • Left main coronary artery disease
  • Multivessel disease
  • Lesions located at a distance ≤3 mm from the ostium of the vessel
  • Thrombocytopenia
  • Previous coronary artery bypass grafting
  • Previous coronary intervention with stent implantation or balloon angioplasty
  • Previous use of novel oral anticoagulants or vitamin K antagonists

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Interventions

DIAGNOSTIC_TESTOCT examination

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

DIAGNOSTIC_TESTBlood sampling

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

DIAGNOSTIC_TESTAssessment 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


Locations(1)

Medical University of Warsaw

Warsaw, Masovian Voivodeship, Poland

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NCT06275399


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