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RECRUITING
NCT06275399

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

Sponsor: Medical University of Warsaw

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

105

Start Date

2023-07-21

Completion Date

2026-07-21

Last Updated

2024-02-23

Healthy Volunteers

No

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

Locations (1)

Medical University of Warsaw

Warsaw, Masovian Voivodeship, Poland